Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-17 @ 3:15 PM
Study NCT ID:
NCT06183450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hearing and Cognition in Aging Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011304', 'term': 'Presbycusis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 262}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2033-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-12-06', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pure-ton audiometry', 'timeFrame': '5 years', 'description': 'Pure-tone audiometry will be evaluated by collecting the threshold in air and bone conduction for both ears on each frequency tested (125-250-500-1000-2000-4000 and 8000 Hz), as well as the average hearing loss (MAP ) on all five frequencies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['presbycusis', 'aging', 'cognitive decline', 'speech in noise', 'sound localisation', 'hearing loss'], 'conditions': ['Presbycusis']}, 'descriptionModule': {'briefSummary': 'This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders', 'detailedDescription': 'The aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. This project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. The data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult normal hearing subjects aged between 45 and 50 years old.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal hearing (Pure Tone Audiometry \\< or = 20 dB)\n* Residency in one of the three neighborhoods :\n* Affiliation with a social security system\n\nExclusion Criteria:\n\n* Individuals under guardianship, trusteeship or curators\n* History of neurological pathologies\n* Taking of psychotropic medication.'}, 'identificationModule': {'nctId': 'NCT06183450', 'acronym': 'ACAV', 'briefTitle': 'Hearing and Cognition in Aging Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Hearing and Cognition in Aging Adults', 'orgStudyIdInfo': {'id': 'RC31/22/0252'}, 'secondaryIdInfos': [{'id': '2023-A01415-40', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'hearing subject', 'description': 'Adult normal hearing subjects, evaluated annually for 5 years,', 'interventionNames': ['Diagnostic Test: auditory level', 'Diagnostic Test: cognitive level', 'Diagnostic Test: quality of life level']}], 'interventions': [{'name': 'auditory level', 'type': 'DIAGNOSTIC_TEST', 'description': '* Evaluation of auditory thresholds through audiometric tests.\n* Evaluation of speech comprehension in noise through a vocal audiometry test in noise (FraMatrix).\n* Evaluation of spatial auditory behavior and spatial precision using a spatial discrimination test (Minimum Audible Angle) and a static sound localization test in virtual reality.', 'armGroupLabels': ['hearing subject']}, {'name': 'cognitive level', 'type': 'DIAGNOSTIC_TEST', 'description': "* Evaluation of attention and short-term memory functions with verbal and non-verbal tasks: Digit Span Test and Reading Span Test.\n* Evaluation of inhibition capacities using the Stroop Test.\n* Evaluation of executive functions, visual attention, reasoning, and mental arithmetic using the Raven's Matrix test.", 'armGroupLabels': ['hearing subject']}, {'name': 'quality of life level', 'type': 'DIAGNOSTIC_TEST', 'description': '\\- Evaluation of quality of live level via Speech, Spatial and Qualities of Hearing Scale (SSQ-12) and EuroQol-5D questionnaires.', 'armGroupLabels': ['hearing subject']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cahors', 'country': 'France', 'contacts': [{'name': 'Mariam ALZAHER, Dr', 'role': 'CONTACT'}], 'facility': "Ecole d'audioprothèse", 'geoPoint': {'lat': 44.4491, 'lon': 1.43663}}], 'centralContacts': [{'name': 'Mathieu Marx, Pr', 'role': 'CONTACT', 'email': 'marx.m@chu-toulouse.fr', 'phone': '05 61 77 77 04', 'phoneExt': '+33'}, {'name': 'Mariam ALZAHER, Dr', 'role': 'CONTACT', 'email': 'mariam.alzaher@cnrs.fr'}], 'overallOfficials': [{'name': 'Mathieu Marx, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}