Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT07226167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hearing Aid Benefit in Real-World Noisy Environments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, '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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-11-03', 'studyFirstSubmitQcDate': '2025-11-03', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare effectiveness of hearing aid signal enhancement on speech perception', 'timeFrame': '1 week', 'description': 'Participants will hear 3 different, 5 minute listening scenarios and answer the same survey questions for each. They will rate perception from 0% (understood nothing) to 100% (understood everything). Percentages will be compared across the 3 scenarios.'}, {'measure': 'Compare effectiveness of hearing aid signal enhancement on listening effort', 'timeFrame': '1 week', 'description': 'Participants will hear 3 different, 5 minute listening scenarios and answer the same survey questions for each. They will rate how hard they had to work to understand what was said from 0% (no effort) to 100% (extremely hard). Percentages will be compared across the 3 scenarios.'}, {'measure': 'Compare effectiveness of hearing aid signal enhancement on listening comfort', 'timeFrame': '1 week', 'description': 'Participants will hear 3 different, 5 minute listening scenarios and answer the same survey questions for each. They will rate how comfortable it was to listen from 0% (very comfortable) to 100% (very uncomfortable). Percentages will be compared across the 3 scenarios.'}, {'measure': 'Compare effectiveness of hearing aid signal enhancement on sound quality', 'timeFrame': '1 week', 'description': 'Participants will hear 3 different, 5 minute listening scenarios and answer the same survey questions for each. They will rate the sound quality from 0% (very poor) to 100% (excellent). Percentages will be compared across the 3 scenarios.'}, {'measure': 'Compare effectiveness of hearing aid signal enhancement on sound location', 'timeFrame': '1 week', 'description': 'Participants will hear 3 different, 5 minute listening scenarios and answer the same survey questions for each. They will rate how easy it was to tell where the sound was coming from, from 0% (could not tell) to 100% (very easy). Percentages will be compared across the 3 scenarios.'}, {'measure': 'Compare effectiveness of hearing aid algorithms based on location', 'timeFrame': '1 week', 'description': 'Participants will complete the same survey questions for all three algorithms. Participants will select which option best describes the environment they are in when completing the hearing survey.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Aid', 'Hearing Loss, Bilateral Sensorineural', 'Hearing Loss, Adult-Onset']}, 'descriptionModule': {'briefSummary': "Researchers are doing this study to understand why hearing aids often work well in controlled laboratory settings but don't provide the same level of benefit in everyday noisy environments. The questions they hope to answer are:\n\n* What factors contribute to hearing aid benefit in noisy environments\n* What factors limit hearing aid benefit\n* How do real-world factors interact with common hearing aid settings\n\nParticipants will complete:\n\n* Hearing and listening tests\n* Memory and attention assessment\n* Surveys on their Smartphone", 'detailedDescription': 'This is study investigates how hearing aid signal processing algorithms and environmental factors in listening situations interact to affect listening outcomes. A crossover design is used to assess speech perception, listening effort, and user satisfaction across diverse acoustic contexts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old\n* Symmetrical, bilateral, adult onset, sensorineural hearing loss\n* Experienced hearing aid users (\\> 3 months)\n\nExclusion Criteria:\n\n* Under 18 years old\n* Conductive or mixed hearing loss\n* Asymmetrical or unilateral hearing loss\n* Pre-lingual or childhood hearing loss onset\n* No hearing aid experience'}, 'identificationModule': {'nctId': 'NCT07226167', 'briefTitle': 'Hearing Aid Benefit in Real-World Noisy Environments', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Evaluating the Impact of Hearing Aid Signal Enhancement Algorithms in Real-World Contexts', 'orgStudyIdInfo': {'id': '2025-1586'}, 'secondaryIdInfos': [{'id': 'FA', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'UWMSN | L&S | Communication Sc', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 11/25/25', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing aid + smartphone surveys', 'description': 'Participants will use study-provided hearing aids', 'interventionNames': ['Device: Hearing aid']}], 'interventions': [{'name': 'Hearing aid', 'type': 'DEVICE', 'description': 'Participants will use study-provided hearing aids for 15 minutes, 7-10 times for a week.', 'armGroupLabels': ['Hearing aid + smartphone surveys']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'contacts': [{'name': 'Lucas Modahl', 'role': 'CONTACT', 'email': 'lmodahl@wisc.edu'}, {'name': 'Erik Jorgensen, AuD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'centralContacts': [{'name': 'Lucas Modahl', 'role': 'CONTACT', 'email': 'lmodahl@wisc.edu'}], 'overallOfficials': [{'name': 'Erik Jorgensen, AuD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}