Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 11:04 AM
Study NCT ID:
NCT05372094
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2022-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Noise Reduction Preferences in Teenagers and Pre-teens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'phonakaudiologyresearch@gmail.com', 'phone': '630-821-5000', 'title': 'Director of Research', 'organization': 'Sonova US'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Rating of Listening Effort Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'classes': [{'title': 'Subjective rating with NR OFF', 'categories': [{'measurements': [{'value': '44.73', 'spread': '27.54', 'groupId': 'OG000'}]}]}, {'title': 'Subjective rating with NR at custom setting', 'categories': [{'measurements': [{'value': '44.5', 'spread': '27.45', 'groupId': 'OG000'}]}]}, {'title': 'Subjective rating with NR at WEAK', 'categories': [{'measurements': [{'value': '41.53', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Subjective rating with NR at STRONG', 'categories': [{'measurements': [{'value': '35.86', 'spread': '26.91', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000'], 'groupDescription': 'Fixed factor of program and random intercept of participant', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.05', 'groupIds': ['OG000'], 'groupDescription': 'Follow up comparison between noise reduction setting OFF and noise reduction setting STRONG', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.01', 'groupIds': ['OG000'], 'groupDescription': 'Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAK', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '>.05', 'groupIds': ['OG000'], 'groupDescription': 'Follow up comparison between ratings of effort with "OFF" and "WEAK"', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of study, visit 2', 'description': 'Participant will rate perceived listening effort during a speech in noise task with different levels of noise reduction. Participants will rate how easy the task seemed using a sliding scale with 100 increments between two verbal anchors: "it was very easy" to "it was not easy at all". Higher scores indicate higher perceived listening effort. A rating of "0" would indicate "it was very easy" to understand the speech while a rating of "100" would indicate "it was not easy at all" to understand the speech.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the testing except three identified outliers (two who never wore hearing aids and one who was not able to complete activities assigned during the home trial)'}, {'type': 'SECONDARY', 'title': 'Speech Reception Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'classes': [{'title': 'SNR50 with NR setting OFF', 'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.13'}]}]}, {'title': 'SNR50 with NR setting WEAK', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.17'}]}]}, {'title': 'SNR50 with NR setting MODERATE', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.95', 'upperLimit': '1.14'}]}]}, {'title': 'SNR50 with NR setting at STRONG', 'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.17'}]}]}], 'analyses': [{'pValue': '0.283', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 28, visit 3', 'description': 'The signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction, known as SNR50. A lower number is better, as it indicates that the words do not have to be presented at a much higher level than the noise in order for the person to understand 50% of the words. For example, an SNR of 2 dB means that the words are 2 dB louder than the noise, and SNR of 0 dB means that the words and the noise are at the same level, etc.', 'unitOfMeasure': 'decibels (dB)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the task except three identified outliers.'}, {'type': 'SECONDARY', 'title': 'Physical Response Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'classes': [{'title': 'Response time with NR OFF', 'categories': [{'measurements': [{'value': '2452.65', 'spread': '561.43', 'groupId': 'OG000'}]}]}, {'title': 'Response time with NR WEAK', 'categories': [{'measurements': [{'value': '2432.16', 'spread': '509.75', 'groupId': 'OG000'}]}]}, {'title': 'Response time with NR STRONG', 'categories': [{'measurements': [{'value': '2388.25', 'spread': '468.62', 'groupId': 'OG000'}]}]}, {'title': 'Response time with NR at a custom setting', 'categories': [{'measurements': [{'value': '2367.7', 'spread': '448.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.145', 'groupIds': ['OG000'], 'groupDescription': 'Analysis was done only between NR OFF and NR at a custom or preferred setting.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of study, visit 2', 'description': 'Length of time(in milliseconds) it takes participant to respond physically by pressing a button while also performing a verbal task. Participants repeat the word they hear, while at the same time, are instructed to press a button if the word they hear is an object "bigger than a basketball". A higher response time may indicate increased listening effort.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were able to complete the task excluding three outliers who were excluded from all analyses and one participant who was unable to perform this task.'}, {'type': 'SECONDARY', 'title': 'Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'classes': [{'title': 'Preferred NR off', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Preferred NR at individual preferred setting', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Preferred OFF and preferred setting the same', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3018', 'groupIds': ['OG000'], 'groupDescription': 'An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.', 'statisticalMethod': 'Exact Binomial test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 of study, visit 1', 'description': 'A blinded paired comparison between two different settings of noise reduction (NR), while listening to a story presented in noise. Participants indicate whether they prefer listening to setting "A" or setting "B". Investigator will switch the settings so that participant is not aware of what the settings are. There will be a total of 18 trials; 12 which will compare OFF to either WEAK or STRONG, and six trials will compare WEAK to STRONG. The preferred setting will be determined by counting which setting is chosen most often from those six trials. The outcome measure data will report a count of participants who preferred OFF to their chosen setting, who preferred their chosen setting to OFF, and those who chose OFF and their preferred setting an equal number of times.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the task excluding three identified outliers who were excluded from all analyses.'}, {'type': 'SECONDARY', 'title': 'Subjective Questionnaire on Preference for Accessing Bluetooth on Phone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'classes': [{'title': 'Prefer tapping to access streaming over using phone controls or hearing aid button', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Prefer tapping to answer phone call over using phone or hearing aid button', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Prefer tapping to access voice assistant over using phone control or hearing aid button', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.1796', 'groupIds': ['OG000'], 'groupDescription': 'Exact binomial test was done to evaluate if the majority (\\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.', 'statisticalMethod': 'Exact Binomial test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28, visit 3', 'description': 'Subjective questionnaire about streaming access preferences. Participants will indicate which method (Hearing aid push button, phone control, or tap control on hearing aid) for answering phone calls and listening to audio streaming on phone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed testing excluding three identified outliers and one participant who did not use Tap Control during the home trial period.'}, {'type': 'SECONDARY', 'title': 'Verbal Response Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'classes': [{'title': 'Noise Reduction setting OFF', 'categories': [{'measurements': [{'value': '14.37', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '18'}]}]}, {'title': 'Noise Reduction setting WEAK', 'categories': [{'measurements': [{'value': '14.17', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '19'}]}]}, {'title': 'Noise Reduction setting STRONG', 'categories': [{'measurements': [{'value': '13.93', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '18'}]}]}, {'title': 'NR setting CUSTOM', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of study, visit 2', 'description': 'Out of 25 monosyllabic words presented in noise at different levels of noise reduction, the number of words the participant correctly repeats,while also performing a visual task. No statistical analysis was performed for this test.', 'unitOfMeasure': 'words repeated correctly', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the task excluding three identified outliers who were excluded from all analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.\n\nPhonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14.33', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-30', 'size': 343268, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-05T16:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants will be blinded as to which noise reduction setting they are listening to during lab visit objective testing only.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2022-05-03', 'resultsFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-03', 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Rating of Listening Effort Questionnaire', 'timeFrame': 'Day 14 of study, visit 2', 'description': 'Participant will rate perceived listening effort during a speech in noise task with different levels of noise reduction. Participants will rate how easy the task seemed using a sliding scale with 100 increments between two verbal anchors: "it was very easy" to "it was not easy at all". Higher scores indicate higher perceived listening effort. A rating of "0" would indicate "it was very easy" to understand the speech while a rating of "100" would indicate "it was not easy at all" to understand the speech.'}], 'secondaryOutcomes': [{'measure': 'Speech Reception Threshold', 'timeFrame': 'Day 28, visit 3', 'description': 'The signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction, known as SNR50. A lower number is better, as it indicates that the words do not have to be presented at a much higher level than the noise in order for the person to understand 50% of the words. For example, an SNR of 2 dB means that the words are 2 dB louder than the noise, and SNR of 0 dB means that the words and the noise are at the same level, etc.'}, {'measure': 'Physical Response Time', 'timeFrame': 'Day 14 of study, visit 2', 'description': 'Length of time(in milliseconds) it takes participant to respond physically by pressing a button while also performing a verbal task. Participants repeat the word they hear, while at the same time, are instructed to press a button if the word they hear is an object "bigger than a basketball". A higher response time may indicate increased listening effort.'}, {'measure': 'Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings', 'timeFrame': 'Day 1 of study, visit 1', 'description': 'A blinded paired comparison between two different settings of noise reduction (NR), while listening to a story presented in noise. Participants indicate whether they prefer listening to setting "A" or setting "B". Investigator will switch the settings so that participant is not aware of what the settings are. There will be a total of 18 trials; 12 which will compare OFF to either WEAK or STRONG, and six trials will compare WEAK to STRONG. The preferred setting will be determined by counting which setting is chosen most often from those six trials. The outcome measure data will report a count of participants who preferred OFF to their chosen setting, who preferred their chosen setting to OFF, and those who chose OFF and their preferred setting an equal number of times.'}, {'measure': 'Subjective Questionnaire on Preference for Accessing Bluetooth on Phone', 'timeFrame': 'Day 28, visit 3', 'description': 'Subjective questionnaire about streaming access preferences. Participants will indicate which method (Hearing aid push button, phone control, or tap control on hearing aid) for answering phone calls and listening to audio streaming on phone.'}, {'measure': 'Verbal Response Accuracy', 'timeFrame': 'Day 14 of study, visit 2', 'description': 'Out of 25 monosyllabic words presented in noise at different levels of noise reduction, the number of words the participant correctly repeats,while also performing a visual task. No statistical analysis was performed for this test.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.', 'detailedDescription': 'The purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid Bluetooth streaming programs for this population. Subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. Blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. These tasks will be done using different levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control).\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild, moderate, or moderate-severe bilateral sensorineural hearing loss\n* native English speakers with ability to communicate verbally\n* able to read and follow directions\n* access to smartphone and willing to download a hearing aid app\n* experienced hearing aid user (6+ months)\n\nExclusion Criteria:\n\n* unable to follow verbal directions\n* unable to communicate verbally\n* unable to wear study devices for required home trials\n* active middle ear infection\n* unable to attend lab visits required for study'}, 'identificationModule': {'nctId': 'NCT05372094', 'briefTitle': 'Noise Reduction Preferences in Teenagers and Pre-teens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sonova AG'}, 'officialTitle': 'Noise Reduction Preferences in Teenagers and Pre-teens', 'orgStudyIdInfo': {'id': 'SRF-802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.', 'interventionNames': ['Device: Phonak Hearing Aid']}], 'interventions': [{'name': 'Phonak Hearing Aid', 'type': 'DEVICE', 'description': 'Commercially available hearing aid with various noise reduction strengths', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual participant data will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonova AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vanderbilt University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}