Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02122458
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2014-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blast Exposed Veterans With Auditory Complaints
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001308', 'term': 'Auditory Perceptual Disorders'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001304', 'term': 'Auditory Diseases, Central'}, {'id': 'D012181', 'term': 'Retrocochlear Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Sheila.Pratt@va.gov', 'phone': '412-979-3157', 'title': 'Sheila R. Pratt, Ph.D.', 'organization': 'VA Pittsburgh Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The hearing aid treatment portion of this study was preliminary in nature and limited by the number of participants enrolled and amount of time with which those enrolled wore their hearing aids. Problems with hearing aid wear-time compliance limited interpretation and applicability.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year.', 'description': 'This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-treatment Diagnostic Testing: Normal', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.', 'otherNumAtRisk': 82, 'deathsNumAtRisk': 82, 'otherNumAffected': 0, 'seriousNumAtRisk': 82, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Non-treatment Diagnostic Testing: Blast-exposed Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Non-treatment Diagnostic Testing: Blast-exposed With PTSD', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Non-treatment Diagnostic Testing: PTSD Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Middle ear infection and mass', 'notes': 'One participant acquired an ear infection that required referral for medical intervention. The infection failed to resolve and eventually a middle ear mass was diagnosed. The participant was withdrawn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 82, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hearing Handicap Inventory for Adults (HHIA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.20', 'groupId': 'OG000', 'lowerLimit': '19.04', 'upperLimit': '33.33'}, {'value': '37.34', 'groupId': 'OG001', 'lowerLimit': '31.37', 'upperLimit': '43.32'}, {'value': '19.21', 'groupId': 'OG002', 'lowerLimit': '10.48', 'upperLimit': '27.95'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.448', 'ciLowerLimit': '-8.66', 'ciUpperLimit': '9.56', 'pValueComment': 'Given the preliminary nature of this treatment study and the small number of participants the p-value was not adjusted for multiple comparisons.', 'groupDescription': 'The null hypothesis evaluated by the HHIA was that self-perceived hearing handicap would not reduce from baseline to 6-months post-fitting.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'An Adjusted Rank Transform was applied to the data prior to applying the mixed model analyses.'}], 'paramType': 'MEAN', 'timeFrame': 'The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.', 'description': 'Self-perceived hearing handicap was measured with the Hearing Handicap Inventory for Adults (HHIA), pre- and 6-months post-hearing aid fitting. The minimum score is 0 and the maximum score is 100, with the higher score reflecting greater handicap (worse outcome). The data are presented as a comparison between the two questionnaire administrations (pre- and 6-months post-fitting). The null hypothesis tested was that there would be no difference between the HHIA administered at baseline (pre-fitting) and 6-months post-fitting for all groups.', 'unitOfMeasure': 'Scale score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 37 participants did not complete the treatment. The handicap scale was administered twice (pre-fitting and 6-months post-fitting) to the three groups. The Outcome Measure Data Table reflect comparisons between the overall scores for the 2 questionnaire administrations.'}, {'type': 'PRIMARY', 'title': 'Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Hearing Aid Treatment: Blast-Exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}], 'classes': [{'categories': [{'measurements': [{'value': '-.362', 'spread': '.301', 'groupId': 'OG000'}, {'value': '-.270', 'spread': '.821', 'groupId': 'OG001'}, {'value': '-.080', 'spread': '.331', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Given the small sample size and the preliminary nature of this study, the p-value was not adjusted for multiple comparisons.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).', 'description': 'The Abbreviated Profile of Hearing Aid Benefit (APHAB) was administered at the end of the treatment period (6-months post-fitting) to measure self-perceived benefit. The APHAB is a 24-item self-assessment inventory used to indicate the extent to which listeners experience listening difficulties (with and without hearing aids) in various settings. The questionnaire uses a 7-point scale that corresponds to the frequency with which difficulties are experienced (99 to 1% of the time). The APHAB was administered for both unaided listening and aided listening, and benefit was calculated by subtracting the mean aided scores from the mean unaided scores. Higher benefit scores (e.g., 99% unaided - 25% aided vs. 99% unaided - 50% aided) reflected greater benefit (better outcome) and negative scores were possible. The null hypothesis tested was that no hearing aid benefit would be demonstrated by any of the 3 groups at 6-months post-fitting.', 'unitOfMeasure': 'Scale score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 36 participants did not complete the treatment. The APHAB benefit data shown here were collected at 6-months post-fitting (end of the treatment) from the 3 groups of participants. One APHAB (aided and unaided portions) was completed per participant.'}, {'type': 'PRIMARY', 'title': 'Intent to Continue Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Hearing Aid Treatment: Blast-Exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG001', 'title': 'Immediate Hearing Aid Treatment: Blast-Exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-fitting', 'description': 'The participants reported whether they would continue to use their hearing aids after the study has ended. The null hypothesis tested was that neither group would demonstrate a significant preference for retaining their hearing aids.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 36 participants did not complete the treatment. The data shown here were collected at 6-months post-fitting (end of the treatment) from the 3 groups of participants.'}, {'type': 'SECONDARY', 'title': 'Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hearing aid use time was collected at 6 months post-fitting.', 'description': 'Hearing aid use time was the number of participants who wore their hearing aids for an average of at least 4 hours per day. The average number of hours that the participants used their hearing aids was measured by their hearing aid data logging systems. These data were collected at the end of the treatment interval for each participant and were considered a positive outcome if they wore their hearing aids at least 4 hours a day on average after 1 month of use. The null hypothesis tested was that none of the participants in the three groups would not demonstrate hearing aid use time 4 hours or more, on average per day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These data are a count of participants who wore their hearing aids at least 4 hours per day on average after 1 month of use. A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 37 participants did not complete the treatment.'}, {'type': 'SECONDARY', 'title': 'Speech Perception in Quiet and in Noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'OG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}], 'classes': [{'title': 'Pre-fitting Score in Quiet', 'categories': [{'measurements': [{'value': '.92', 'spread': '.017', 'groupId': 'OG000'}, {'value': '.93', 'spread': '.013', 'groupId': 'OG001'}, {'value': '.95', 'spread': '.018', 'groupId': 'OG002'}]}]}, {'title': 'Pre-fitting Score in Noise', 'categories': [{'measurements': [{'value': '.69', 'spread': '.044', 'groupId': 'OG000'}, {'value': '.73', 'spread': '.033', 'groupId': 'OG001'}, {'value': '.72', 'spread': '.047', 'groupId': 'OG002'}]}]}, {'title': '1-week Post-fitting Test Score in Quiet', 'categories': [{'measurements': [{'value': '.96', 'spread': '.018', 'groupId': 'OG000'}, {'value': '.93', 'spread': '.014', 'groupId': 'OG001'}, {'value': '.95', 'spread': '.019', 'groupId': 'OG002'}]}]}, {'title': '1-week Post-fitting Test Score in Noise', 'categories': [{'measurements': [{'value': '.83', 'spread': '.046', 'groupId': 'OG000'}, {'value': '.79', 'spread': '.035', 'groupId': 'OG001'}, {'value': '.79', 'spread': '.049', 'groupId': 'OG002'}]}]}, {'title': 'Final Test Score in Quiet', 'categories': [{'measurements': [{'value': '.96', 'spread': '.009', 'groupId': 'OG000'}, {'value': '.95', 'spread': '.007', 'groupId': 'OG001'}, {'value': '.95', 'spread': '.010', 'groupId': 'OG002'}]}]}, {'title': 'Final Test Score in Noise', 'categories': [{'measurements': [{'value': '.84', 'spread': '.037', 'groupId': 'OG000'}, {'value': '.82', 'spread': '.028', 'groupId': 'OG001'}, {'value': '.71', 'spread': '.040', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).', 'description': "The participants' speech perception was measured at the word level with the California Consonant Test (CCT). The CCT is a 50 item a closed-set word identification test. It was administered at 3 timepoints (pre-fitting, 1-week post-fitting, and 6-months post-fitting), with testing was completed in quiet and in background noise (speech babble, +3 dB signal/babble) at each timepoint. The participants were unaided during the pre-fitting testing but wore their hearing aids during the two post-fitting sessions. The outcome measure was the proportion of correct trials out of 50. A correct trial consisted of an accurate identification of the target word presented to the participant in the sound-field at 40 dB sensation level. The null hypothesis tested was that speech perception would not improve over the treatment intervals for the groups for either test condition (quiet and noise).", 'unitOfMeasure': 'Proportion Correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 37 participants did not complete the treatment and are not reflected in the data reported here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'FG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'FG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}, {'id': 'FG003', 'title': 'Non-treatment Diagnostic Testing: Normal', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.'}, {'id': 'FG004', 'title': 'Non-treatment Diagnostic Testing: Blast-exposed Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.'}, {'id': 'FG005', 'title': 'Non-treatment Diagnostic Testing: Blast-exposed With PTSD', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.'}, {'id': 'FG006', 'title': 'Non-treatment Diagnostic Testing: PTSD Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '82'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '43'}, {'groupId': 'FG006', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Did not qualify at initial testing or after chart review', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Experimental Error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Deployed or Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Scheduling Delays - Unable to Complete', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The participants were recruited through flyers, letters, VA audiologists, and Veteran organizations. Recruitment activities occurred Year 1 through Year 4 of the study.\n\nIt should be noted that the participants enrolled in the hearing aid treatment arms (clinical trial portion of the study) completed diagnostic testing prior to completing the hearing aid treatment. The remaining participants only completed the diagnostic testing (Non-treatment Diagnostic Testing).', 'preAssignmentDetails': 'Preliminary testing and review of clinical records excluded 137 participants prior to group assignment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '226', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'BG001', 'title': 'Immediate Hearing Aid Treatment: Blast-exposed With PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.'}, {'id': 'BG002', 'title': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.'}, {'id': 'BG003', 'title': 'Non-treatment Diagnostic Testing: Normal', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.'}, {'id': 'BG004', 'title': 'Non-treatment Diagnostic Testing: Blast-exposed Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.'}, {'id': 'BG005', 'title': 'Non-treatment Diagnostic Testing: Blast-exposed With PTSD', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.'}, {'id': 'BG006', 'title': 'Non-Treatment Diagnostic Testing: PTSD Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.01', 'spread': '8.63', 'groupId': 'BG000'}, {'value': '37.46', 'spread': '6.73', 'groupId': 'BG001'}, {'value': '39.21', 'spread': '8.47', 'groupId': 'BG002'}, {'value': '35.23', 'spread': '8.29', 'groupId': 'BG003'}, {'value': '35.32', 'spread': '6.72', 'groupId': 'BG004'}, {'value': '34.52', 'spread': '6.42', 'groupId': 'BG005'}, {'value': '34.85', 'spread': '8.10', 'groupId': 'BG006'}, {'value': '37.08', 'spread': '7.77', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Participants by Sex', 'categories': [{'title': 'Number of Male Participants Per Arm', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '175', 'groupId': 'BG007'}]}, {'title': 'Number of Female Participants Per Arm', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '51', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '21', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '204', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '172', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '226', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age', 'classes': [{'categories': [{'measurements': [{'value': '37.01', 'groupId': 'BG000', 'lowerLimit': '26.4', 'upperLimit': '50.6'}, {'value': '37.46', 'groupId': 'BG001', 'lowerLimit': '27.7', 'upperLimit': '49.1'}, {'value': '39.21', 'groupId': 'BG002', 'lowerLimit': '28.3', 'upperLimit': '50.9'}, {'value': '35.23', 'groupId': 'BG003', 'lowerLimit': '20.6', 'upperLimit': '50.9'}, {'value': '35.32', 'groupId': 'BG004', 'lowerLimit': '23.2', 'upperLimit': '49.9'}, {'value': '34.52', 'groupId': 'BG005', 'lowerLimit': '23.4', 'upperLimit': '48.6'}, {'value': '34.85', 'groupId': 'BG006', 'lowerLimit': '25.10', 'upperLimit': '49.10'}, {'value': '37.08', 'groupId': 'BG007', 'lowerLimit': '20.6', 'upperLimit': '50.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Veterans between the ages of 20 and 50 years of age who had normal hearing on standard audiometric testing, who had significant or no self-reported hearing handicap, significant or no history of blast-exposure, significant or no PTSD, normal vision and no history of prior brain injuries or diseases that were not blast-related. Preliminary testing and review of clinical records excluded 137 participants. These participants are not included in the baseline participant numbers.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-11', 'size': 359603, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-14T01:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The primary study was diagnostic, with a goal of better understanding and determining the best diagnostic assessment battery for capturing the hearing and auditory problems reported by blast-exposed Veterans. The secondary purpose was to implement a preliminary treatment study to determine if blast-exposed Veterans with hearing complaints, but normal audiometric data benefited from low-gain hearing aids. This secondary treatment study is the clinical trial portion of this study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 363}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2014-04-22', 'resultsFirstSubmitDate': '2022-07-05', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-21', 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Handicap Inventory for Adults (HHIA)', 'timeFrame': 'The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.', 'description': 'Self-perceived hearing handicap was measured with the Hearing Handicap Inventory for Adults (HHIA), pre- and 6-months post-hearing aid fitting. The minimum score is 0 and the maximum score is 100, with the higher score reflecting greater handicap (worse outcome). The data are presented as a comparison between the two questionnaire administrations (pre- and 6-months post-fitting). The null hypothesis tested was that there would be no difference between the HHIA administered at baseline (pre-fitting) and 6-months post-fitting for all groups.'}, {'measure': 'Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)', 'timeFrame': 'The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).', 'description': 'The Abbreviated Profile of Hearing Aid Benefit (APHAB) was administered at the end of the treatment period (6-months post-fitting) to measure self-perceived benefit. The APHAB is a 24-item self-assessment inventory used to indicate the extent to which listeners experience listening difficulties (with and without hearing aids) in various settings. The questionnaire uses a 7-point scale that corresponds to the frequency with which difficulties are experienced (99 to 1% of the time). The APHAB was administered for both unaided listening and aided listening, and benefit was calculated by subtracting the mean aided scores from the mean unaided scores. Higher benefit scores (e.g., 99% unaided - 25% aided vs. 99% unaided - 50% aided) reflected greater benefit (better outcome) and negative scores were possible. The null hypothesis tested was that no hearing aid benefit would be demonstrated by any of the 3 groups at 6-months post-fitting.'}, {'measure': 'Intent to Continue Use', 'timeFrame': '6 months post-fitting', 'description': 'The participants reported whether they would continue to use their hearing aids after the study has ended. The null hypothesis tested was that neither group would demonstrate a significant preference for retaining their hearing aids.'}], 'secondaryOutcomes': [{'measure': 'Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)', 'timeFrame': 'Hearing aid use time was collected at 6 months post-fitting.', 'description': 'Hearing aid use time was the number of participants who wore their hearing aids for an average of at least 4 hours per day. The average number of hours that the participants used their hearing aids was measured by their hearing aid data logging systems. These data were collected at the end of the treatment interval for each participant and were considered a positive outcome if they wore their hearing aids at least 4 hours a day on average after 1 month of use. The null hypothesis tested was that none of the participants in the three groups would not demonstrate hearing aid use time 4 hours or more, on average per day.'}, {'measure': 'Speech Perception in Quiet and in Noise', 'timeFrame': 'The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).', 'description': "The participants' speech perception was measured at the word level with the California Consonant Test (CCT). The CCT is a 50 item a closed-set word identification test. It was administered at 3 timepoints (pre-fitting, 1-week post-fitting, and 6-months post-fitting), with testing was completed in quiet and in background noise (speech babble, +3 dB signal/babble) at each timepoint. The participants were unaided during the pre-fitting testing but wore their hearing aids during the two post-fitting sessions. The outcome measure was the proportion of correct trials out of 50. A correct trial consisted of an accurate identification of the target word presented to the participant in the sound-field at 40 dB sensation level. The null hypothesis tested was that speech perception would not improve over the treatment intervals for the groups for either test condition (quiet and noise)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hearing impairment', 'post-traumatic stress disorder', 'traumatic brain injury', 'auditory processing disorder'], 'conditions': ['Hearing Impairment', 'Hearing Aid Fitting']}, 'referencesModule': {'references': [{'pmid': '28981349', 'type': 'BACKGROUND', 'citation': 'Gallun FJ, Papesh MA, Lewis MS. Hearing complaints among veterans following traumatic brain injury. Brain Inj. 2017;31(9):1183-1187. doi: 10.1080/02699052.2016.1274781.'}, {'pmid': '23341279', 'type': 'BACKGROUND', 'citation': 'Gallun FJ, Lewis MS, Folmer RL, Diedesch AC, Kubli LR, McDermott DJ, Walden TC, Fausti SA, Lew HL, Leek MR. Implications of blast exposure for central auditory function: a review. J Rehabil Res Dev. 2012;49(7):1059-74. doi: 10.1682/jrrd.2010.09.0166.'}, {'pmid': '32966118', 'type': 'BACKGROUND', 'citation': 'Koerner TK, A Papesh M, Gallun FJ. A Questionnaire Survey of Current Rehabilitation Practices for Adults With Normal Hearing Sensitivity Who Experience Auditory Difficulties. Am J Audiol. 2020 Dec 9;29(4):738-761. doi: 10.1044/2020_AJA-20-00027. Epub 2020 Sep 23.'}, {'pmid': '21419179', 'type': 'BACKGROUND', 'citation': 'Folmer RL, Billings CJ, Diedesch-Rouse AC, Gallun FJ, Lew HL. Electrophysiological assessments of cognition and sensory processing in TBI: applications for diagnosis, prognosis and rehabilitation. Int J Psychophysiol. 2011 Oct;82(1):4-15. doi: 10.1016/j.ijpsycho.2011.03.005. Epub 2011 Mar 16.'}, {'pmid': '32520849', 'type': 'BACKGROUND', 'citation': 'Papesh MA, Stefl AA, Gallun FJ, Billings CJ. Effects of Signal Type and Noise Background on Auditory Evoked Potential N1, P2, and P3 Measurements in Blast-Exposed Veterans. Ear Hear. 2021 Jan/Feb;42(1):106-121. doi: 10.1097/AUD.0000000000000906.'}, {'pmid': '28418327', 'type': 'BACKGROUND', 'citation': 'Hoover EC, Souza PE, Gallun FJ. Auditory and Cognitive Factors Associated with Speech-in-Noise Complaints following Mild Traumatic Brain Injury. J Am Acad Audiol. 2017 Apr;28(4):325-339. doi: 10.3766/jaaa.16051.'}, {'pmid': '23341276', 'type': 'BACKGROUND', 'citation': 'Gallun FJ, Diedesch AC, Kubli LR, Walden TC, Folmer RL, Lewis MS, McDermott DJ, Fausti SA, Leek MR. Performance on tests of central auditory processing by individuals exposed to high-intensity blasts. J Rehabil Res Dev. 2012;49(7):1005-25. doi: 10.1682/jrrd.2012.03.0038.'}, {'pmid': '20104403', 'type': 'BACKGROUND', 'citation': 'Fausti SA, Wilmington DJ, Gallun FJ, Myers PJ, Henry JA. Auditory and vestibular dysfunction associated with blast-related traumatic brain injury. J Rehabil Res Dev. 2009;46(6):797-810. doi: 10.1682/jrrd.2008.09.0118.'}, {'pmid': '34582257', 'type': 'BACKGROUND', 'citation': 'Reavis KM, Snowden JM, Henry JA, Gallun FJ, Lewis MS, Carlson KF. Blast Exposure and Self-Reported Hearing Difficulty in Service Members and Veterans Who Have Normal Pure-Tone Hearing Sensitivity: The Mediating Role of Posttraumatic Stress Disorder. J Speech Lang Hear Res. 2021 Nov 8;64(11):4458-4467. doi: 10.1044/2021_JSLHR-20-00687. Epub 2021 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study blast-exposed Veterans who report hearing handicap but show normal or near normal results on standard audiometric testing. The characteristics and nature of their auditory and auditory-related skills will be examined, along with whether coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.', 'detailedDescription': 'The purpose of this study is to study blast-exposed Veterans who report hearing handicap but show normal or near normal results on standard audiometric testing. The characteristics and nature of their auditory and auditory-related skills will be examined with a battery of behavioral and physiologic measures. The potential contributions of co-occurring PTSD also will be evaluated. In a preliminary treatment study, a sub-sample of the targeted Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.\n\nThis study consists of two parts. In Part 1, four groups of Veterans, aged 20 - 50 years, will complete a battery of auditory and auditory-related assessments to better understand the deficit sources and patterns. The assessment measures will consist of questionnaires, behavioral tests, and auditory physiologic measures. One group will consist of blast-exposed Veterans with auditory problems but no PTSD. The second group will consist of blast-exposed Veterans with auditory problems plus PTSD. The third group will consist of Veterans with PTSD but no reported auditory problems, and the fourth groups will be a normal control group.\n\nIn Part 2 of the study (clinical trial portion), a smaller group of participants from the first and second groups will be fitted with mild-gain open-fit hearing aids to determine if they benefit from mild high-frequency amplification. Changes in hearing handicap and speech perception will be compared from baseline to 6-months post-fitting. Perceived hearing aid benefit, hearing aid use time, and intent to continue use will be measured at the end of a 6-month treatment period. A delayed treatment group will be formed from group 1 and will be followed over a 12-month period with hearing aids fitted at 6 months. The participants will be assigned randomly from Part 1 of the study.\n\nThe information obtained from this study will help us understand the auditory problems experienced by blast-exposed Veterans and eventually contribute to the development of an efficient and effective assessment battery and intervention approaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 - 50 years; U.S. Veteran;\n* English-speaking;\n* history of blast exposure and no history of blast exposure;\n* history of PTSD and no history of PTSD;\n* self-perceived hearing handicap and no self-perceived hearing handicap;\n* normal or near normal pure tone hearing thresholds;\n* history of brain injury and no history of brain injury;\n* normal vision.\n\nExclusion Criteria:\n\n* hyperacusis;\n* marked tinnitus;\n* pure tone hearing thresholds consistent with a hearing loss;\n* greater the 20/30 vision screening results (corrected or uncorrected);\n* marked speech perception deficits'}, 'identificationModule': {'nctId': 'NCT02122458', 'briefTitle': 'Blast Exposed Veterans With Auditory Complaints', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Blast-exposed Veterans With Auditory Complaints', 'orgStudyIdInfo': {'id': 'C1164-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.', 'interventionNames': ['Device: mild-gain hearing aids with high-frequency emphasis over 6-months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate Hearing Aid Treatment: Blast-exposed with PTSD', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.', 'interventionNames': ['Device: mild-gain hearing aids with high-frequency emphasis over 6-months']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Hearing Aid Treatment: Blast-exposed Only', 'description': 'This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.', 'interventionNames': ['Device: mild-gain hearing aids with high-frequency emphasis over 6-months']}, {'type': 'NO_INTERVENTION', 'label': 'Non-treatment Diagnostic Testing: Normal', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.'}, {'type': 'NO_INTERVENTION', 'label': 'Non-Treatment Diagnostic Testing: Blast-exposed Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.'}, {'type': 'NO_INTERVENTION', 'label': 'Non-treatment Diagnostic Testing: Blast-exposed with PTSD', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.'}, {'type': 'NO_INTERVENTION', 'label': 'Non-treatment Diagnostic Testing: PTSD Only', 'description': 'This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.'}], 'interventions': [{'name': 'mild-gain hearing aids with high-frequency emphasis over 6-months', 'type': 'DEVICE', 'otherNames': ['hearing aids'], 'description': 'open-fit hearing aids with mild amplification in the high frequencies.', 'armGroupLabels': ['Delayed Hearing Aid Treatment: Blast-exposed Only', 'Immediate Hearing Aid Treatment: Blast-exposed Only', 'Immediate Hearing Aid Treatment: Blast-exposed with PTSD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '57117-5046', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sioux Falls VA Health Care System, Sioux Falls, SD', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Sheila R Pratt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available at the conclusion of the study and after publication of planned study manuscripts. The time will not be limited.', 'ipdSharing': 'YES', 'description': 'De-identified Individual participant data and the study data dictionary will be made available upon request to the PI (spratt@pitt.edu).', 'accessCriteria': 'Those requesting data will need to provide a plan for how the data will be used.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}