Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT06560918
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2024-08-15', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing Aid Self-Efficacy', 'timeFrame': '1 week', 'description': 'Measured in unaided and aided condition'}], 'secondaryOutcomes': [{'measure': 'Willingness to adopt hearing aids', 'timeFrame': '1 week', 'description': 'Their readiness for adoption using the modified URICA'}, {'measure': 'hearing aid satisfaction', 'timeFrame': '1 week', 'description': 'using the SADL'}, {'measure': 'emotional state', 'timeFrame': '1 week', 'description': 'in the unaided and aided condition using the PANAS-SF'}, {'measure': 'Hearing-related Quality of Life', 'timeFrame': '1 week', 'description': 'Using one-question reflecting degree of change in quality of life'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss, Sensorineural']}, 'descriptionModule': {'briefSummary': "This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence and success with over-the-counter (OTC) hearing aids.\n\nThe main questions it aims to answer are:\n\n* Can the SEBAR improve participants' confidence related to managing their over-the-counter hearing aids?\n* Can the SEBAR improve participants' willingness to adopt over-the-counter hearing aids, their satisfaction, quality of life, and their emotional state? Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids.\n\nParticipants will:\n\n* Visit for one appointment to complete a few questionnaires without OTC hearing aids\n* Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences\n* Visit for a second appointment to complete the same questionnaires with OTC hearing aids.", 'detailedDescription': "The proposed study will use a single-arm pre-post intervention research design to achieve both the aims. Participants will complete two appointments. Assessments in the first appointment will serve as the baseline (unaided). This will be followed by a week of OTC HA use and SEBAR implementation in their natural listening situations and the outcome measures will be completed again in appointment 2 (aided) to reflect the impact of wearing OTC HAs. Scores on the outcome measures will be compared between the unaided and the aided conditions to answer both the aims. Both the appointments in the proposed study will be completed in the shared and dedicated research spaces in the Department of Audiology and Speech Pathology, College of Health Professions at the University of Arkansas for Medical Sciences. The research proposal will be submitted for the university's Institutional Review Board's approval Upon arrival participants will complete the consent process in which the PI will describe in detail all study procedures, risks and benefits of the study, and the lack of negative consequences should the participant choose to withdraw from the study or cease participation during data collection. Once the consent form has been signed, the participant will complete two appointments.\n\nAppointment 1: For each interested participant, a standard audiometric procedure will be completed to confirm their eligibility. Once the eligible participants consent, preliminary measures will be completed. Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy, willingness to adopt HAs, expected HA satisfaction, current emotional state, and quality of life. At this time, OTC HAs will be fitted to the participants and they will receive the SEBAR. Participants will be instructed to use the HAs for at least 4 hours every day for the next week. Finally, the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher.\n\nAppointment 2: At this appointment, data from the EMA app during the one-week field trial will be stored. HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants' preferred settings. All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 - 85 years old\n\n * Non-fluctuating, adult-onset, bilateral mild-to-moderate sensorineural hearing loss (average hearing thresholds for 500-3000Hz between 25- and 60-dB HL and no more than 10 dB difference between ears).\n * No previous experience with hearing aids\n * English as their first language with good self-reported health\n\nExclusion Criteria:\n\n* Any reported history of outer or middle ear pathologies • No participants will be excluded based on their gender, race/ethnicity.'}, 'identificationModule': {'nctId': 'NCT06560918', 'briefTitle': 'Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing Aids', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes With Over-the-Counter Hearing Aids: A Pilot Study', 'orgStudyIdInfo': {'id': '297731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-post single arm design', 'description': 'Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids.', 'interventionNames': ['Device: hearing aids']}], 'interventions': [{'name': 'hearing aids', 'type': 'DEVICE', 'description': 'OTC devices for a week', 'armGroupLabels': ['Pre-post single arm design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lipika Sarangi, Ph.D.', 'role': 'CONTACT', 'email': 'lsarangi@uams.edu', 'phone': '501-526-5602'}], 'facility': 'Department of Audiology, University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'centralContacts': [{'name': 'Lipika Sarangi, Doctor of Philosophy', 'role': 'CONTACT', 'email': 'LSarangi@uams.edu', 'phone': '501-526-5602'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}