Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT05331404
Status:
UNKNOWN
Last Update Posted:
2022-07-05
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D011304', 'term': 'Presbycusis'}], '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'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patient and control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of brain activity', 'timeFrame': 'Month 12', 'description': 'level of brain activity (in ml/100g/min) measured in the auditory regions in PET when the subject performs a spatial localization task'}], 'secondaryOutcomes': [{'measure': 'Life quality by Speech, Spatial and Qualities of Hearing (12)', 'timeFrame': 'Month 12', 'description': 'Speech, Spatial and Qualities of Hearing is a questionnaire specific to the quality of hearing. It has 3 sections; speech hearing, spatial hearing and quality of hearing. This questionnaire contains 15 items evaluated on a scale to 0 (not at all) to 10 (perfectly).'}, {'measure': 'Life quality by Speech, Spatial and Qualities of Hearing (6)', 'timeFrame': 'Month 6', 'description': 'Speech, Spatial and Qualities of Hearing is a questionnaire specific to the quality of hearing. It has 3 sections; speech hearing, spatial hearing and quality of hearing. This questionnaire contains 15 items evaluated on a scale to 0 (not at all) to 10 (perfectly).'}, {'measure': 'life quality by Hearing Handicap Inventory For The Elderly Screening (12)', 'timeFrame': 'Month 12', 'description': 'Hearing Handicap Inventory For The Elderly Screening contains 10 items to identify the social and emotional difficulties encountered by the subject due to his deafness according to specific situations. It makes it possible to detect the handicap perceived by the person (the higher the score, the greater the perception of the handicap due to hearing loss).'}, {'measure': 'life quality by Hearing Handicap Inventory For The Elderly Screening (6)', 'timeFrame': 'Month 6', 'description': 'Hearing Handicap Inventory For The Elderly Screening contains 10 items to identify the social and emotional difficulties encountered by the subject due to his deafness according to specific situations. It makes it possible to detect the handicap perceived by the person (the higher the score, the greater the perception of the handicap due to hearing loss).'}, {'measure': 'life quality by Short Form Health Survey (12)', 'timeFrame': 'Month 12', 'description': "Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items."}, {'measure': 'life quality by Short Form Health Survey (6)', 'timeFrame': 'Month 6', 'description': "Short Form Health Survey assesses a patient's overall quality of life. It consists of 36 items."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Presbycusis', 'Auditory cortex.', 'Auditory plasticity.', 'Localization', 'Speech-in-noise', 'PET'], 'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '24136826', 'type': 'BACKGROUND', 'citation': 'Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Visual activity predicts auditory recovery from deafness after adult cochlear implantation. Brain. 2013 Dec;136(Pt 12):3682-95. doi: 10.1093/brain/awt274. Epub 2013 Oct 17.'}, {'pmid': '25997394', 'type': 'BACKGROUND', 'citation': 'Vannson N, James C, Fraysse B, Strelnikov K, Barone P, Deguine O, Marx M. Quality of life and auditory performance in adults with asymmetric hearing loss. Audiol Neurootol. 2015;20 Suppl 1:38-43. doi: 10.1159/000380746. Epub 2015 May 19.'}, {'pmid': '28623107', 'type': 'BACKGROUND', 'citation': 'Vannson N, James CJ, Fraysse B, Lescure B, Strelnikov K, Deguine O, Barone P, Marx M. Speech-in-noise perception in unilateral hearing loss: Relation to pure-tone thresholds and brainstem plasticity. Neuropsychologia. 2017 Jul 28;102:135-143. doi: 10.1016/j.neuropsychologia.2017.06.013. Epub 2017 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'Hearing aids restore efficiently some auditory functions in age-related hearing loss (ARHL or presbycusis) providing to the elderly an access to oral communication and a return to social life. However, a most of the assessments of their efficacy focus on speech recognition. Spatial hearing and localization are anothers important auditory functions merely evaluated.\n\nThe purpose of this study is to evaluate the hearing aids benefits for spatial hearing.', 'detailedDescription': 'The main objective is to evaluate the hearing aids benefits for spatial hearing with a multidisciplinary approach combing psychophysics, and Positron Emission Tomography (PET) brain imaging in a before/after experimental design. The novelty of the proposal is both theoretical and methodological: the team aim is to identify neural correlates of spatial hearing after hearing rehabilitation and evaluate the evolution of spatial hearing abilities once subjects with presbycusis are fitted with hearing aids. The assessment of spatial hearing processing will rely on both a virtual visuo-auditory 3D immersive platform and functional neuroimaging using PET scan. This project will provide crucial elements for understanding and improving the rehabilitation of age-related hearing loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor presbyacusics subjects:\n\n* Subjects aged over 50 with a difference in symmetrical audiometric thresholds (\\< 15 dB) between the two ears and requiring hearing aids\n* Affiliation to a social security scheme or equivalent\n* Acceptance of the protocol and signature of the consent form\n\nFor older people with normal hearing:\n\n* Subjects matched in age (+/- 2 years) and gender with the presbycusis group\n* Affiliation to a social security scheme or equivalent\n* Acceptance of the protocol and signature of the consent form\n* Subjects with normal hearing, with hearing thresholds of 20 dB \\< 2kHz and 40 dB \\< 4kHz\n\nFor young people with normal hearing:\n\n* Subjects aged between 18 and 40 years old,\n* Symmetric normal hearing\n* Affiliation to a social security scheme or equivalent\n* Normally hearing subjects with audiometric thresholds \\< 20 dB\n* Acceptance of the protocol and signature of the consent form\n\nExclusion Criteria:\n\n* Persons under a legal protection regime for adults (safeguard of justice, guardianship, curator ship, institutionalized, or under mandate for future protection)\n* History of associated neurological pathology\n* Contraindications to PET\n* Cognitive impairment confirmed by the Montreal Cognitive Assessment (MOCA) test (for presbyacusic subjects and normal-hearing elderly subjects)\n* Taking psychotropic drugs\n* History of epilepsy\n* Pregnant or breastfeeding woman\n* Participation in another intervention protocol'}, 'identificationModule': {'nctId': 'NCT05331404', 'acronym': 'AGEHEAR', 'briefTitle': 'Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Longitudinal Evaluation of Hearing Aids Rehabilitation Within Age-related Hearing Loss Population : Behavioral and Neuroimaging PET Evaluations.', 'orgStudyIdInfo': {'id': 'RC31/20/0365'}, 'secondaryIdInfos': [{'id': '2021-A01993-38', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Presbycusis', 'description': 'Patients with presbycusis who receive rehabilitation with hearing aids', 'interventionNames': ['Radiation: PET examination', 'Other: Quality of life assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aged control group', 'description': 'Aged control group: 15 subjects with normal or near-normal hearing thresholds', 'interventionNames': ['Other: Quality of life assessment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Young control group', 'description': 'Young control group: 15 subjects with normal hearing thresholds', 'interventionNames': ['Radiation: PET examination', 'Other: Quality of life assessment']}], 'interventions': [{'name': 'PET examination', 'type': 'RADIATION', 'description': 'PET examinations with auditory stimuli such as human voice and environmental sounds.', 'armGroupLabels': ['Presbycusis', 'Young control group']}, {'name': 'Quality of life assessment', 'type': 'OTHER', 'description': 'quality of life assessment by :\n\n* Speech, Spatial and Qualities of Hearing\n* Hearing Handicap Inventory For The Elderly Screening\n* Short Form Health Survey', 'armGroupLabels': ['Aged control group', 'Presbycusis', 'Young control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu MARX, PU-PH', 'role': 'CONTACT', 'email': 'marx.m@chu-toulouse.fr', 'phone': '05 61 77 77 04', 'phoneExt': '+33'}, {'name': 'Mathieu MARX, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Mathieu MARX, Professor', 'role': 'CONTACT', 'email': 'marx.m@chu-toulouse.fr', 'phone': '05 61 77 77 04', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Mathieu MARX, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}