Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 5:20 AM
Study NCT ID:
NCT07192757
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Speech in Noise Perception for Individuals With Age-related Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011304', 'term': 'Presbycusis'}], 'ancestors': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-09-09', 'studyFirstSubmitQcDate': '2025-09-17', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Predictive value of audiometric testing', 'timeFrame': '2 weeks', 'description': 'Scores on audiometric battery measures and how they differ in those receiving treatment A compared to those receiving treatment B'}, {'measure': 'Predictive value of brain measures', 'timeFrame': '2 weeks', 'description': 'Level of baseline GABA levels in primary auditory cortex prior to and following intervention in those receiving Treatment A compared to those receiving Treatment B'}], 'primaryOutcomes': [{'measure': 'Speech in noise performance', 'timeFrame': '2 weeks', 'description': 'Percent correct on a speech in noise perception task in participants receiving Treatment A compared to Treatment B'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['age-related hearing loss', 'taVNS', 'vagus nerve stimulation', 'presbycusis', 'hearing aids'], 'conditions': ['Presbycusis']}, 'descriptionModule': {'briefSummary': 'Hearing loss, especially for speech perception in the presence of noise, may lead older individuals to withdraw from social situations. While hearing aids help amplify sound and are useful in many situations, they can be ineffective in noisy contexts. The proposed pilot study will evaluate taVNS for improving speech in noise perception in adults with age-related hearing loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 55-80 years old\n* Normal hearing or age-related hearing loss (with or without hearing aids)\n\nExclusion Criteria:\n\n* History of traumatic brain injury or noise trauma\n* Implanted medical devices (eg., pacemaker) or ferrous metal\n* Known history of heart conditions\n* Medications that impact neurotransmitters released by vagus nerve stimulation'}, 'identificationModule': {'nctId': 'NCT07192757', 'briefTitle': 'Improving Speech in Noise Perception for Individuals With Age-related Hearing Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Improving Speech in Noise Perception for Individuals With Age-related Hearing Loss', 'orgStudyIdInfo': {'id': 'IRB202500769'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'participants will receive low level electrical stimulation to the auricular branch of the vagus nerve during the sound in noise task', 'interventionNames': ['Device: transcutaneous auricular vagus nerve stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'description': 'Participants will receive stimulation to a control location', 'interventionNames': ['Device: Sham Control']}], 'interventions': [{'name': 'transcutaneous auricular vagus nerve stimulation', 'type': 'DEVICE', 'description': 'active electrical stimulation applied to the cymba conchae of the left ear', 'armGroupLabels': ['Treatment A']}, {'name': 'Sham Control', 'type': 'DEVICE', 'description': 'electrical stimulation applied to a location on the ear not innervated by the auricular vagus', 'armGroupLabels': ['Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tracy Centanni, Ph.D.', 'role': 'CONTACT', 'email': 'tracy.centanni@phhp.ufl.edu', 'phone': '352-294-8675'}], 'facility': 'UF Health at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'centralContacts': [{'name': 'Tracy Centanni, PhD', 'role': 'CONTACT', 'email': 'tracy.centanni@phhp.ufl.edu', 'phone': '3522948675'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}