Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05706051
Status:
COMPLETED
Last Update Posted:
2025-08-14
First Post:
2022-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postural Modification and Hearing Aids in Presbycusis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003565', 'term': 'Cytidine Diphosphate'}], 'ancestors': [{'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Ech individual is its proper control'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective study, with analysis of posturography parameters variation before and after hearing aid fitting in age-related hearing loss affected population aged 55 to 80 years old.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elliptic surface variation in posturography assessment before and after hearing aid fitting in presbycusis patients', 'timeFrame': '3 months', 'description': 'analysis of variation of elliptic surface (cm2), eyes opened and closed, and subsequent romberg quotient (elliptic surface closed eyes/elliptic surface opened eyes) in the 3 months before hearing aid fitting and the 3 months after'}], 'secondaryOutcomes': [{'measure': 'the effective wearing time of the device since its installation', 'timeFrame': '3 months', 'description': 'average of time within hearing aid use per day (on the last 3 months)'}, {'measure': 'the severity of the initial hearing loss', 'timeFrame': '3 months', 'description': 'calculation of the average hearing loss measured by the average of the hearing thresholds without a hearing aid at 0.5, 1, 2 and 4 kHz'}, {'measure': 'the notion of a balance disorder described by the patient', 'timeFrame': '3 months', 'description': 'vertigo or feeling of instability'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Age-related hearing loss', 'presbycusis', 'posture', 'Hearing Aid'], 'conditions': ['Age-Related Hearing Loss', 'Postural; Defect', 'Hearing Aid']}, 'descriptionModule': {'briefSummary': 'Presbycusis could be associated to increased risk to fall. There is little about the impact on postural balance of hearing aids. In this study, the investigators describe the postural balance evolution before and after hearing aid fitting in presbycusis-affected adults (55-80years old) consulting Angers University Hospital ENT department and ENT Medical Doctor of Le Mans .', 'detailedDescription': 'After being informed about te study and consentment, patients meeting inclusion criteria consulting for presbycusis and in indication for hearing aids will be included to have posturometry (V0). Posturometry is performed 3 months later, before the first hearing aid installation (V1a) and after (V1b), as well as three months after hearing aid wearing (V2). Evolution of posturometry parameters without hearing aids between V0 and V1a serve as control and is compared to the evolution of posturometry parameters after hearing aid wearing between V1b and V2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 55 to 80 years old\n* ARHL within PTA superior to 30dBHL, and intelligibility threshold 30dB or worse defining hearing aid fitting indication in France\n\nNon inclusion Criteria:\n\n* hearing aid fitting refusal or contrindication\n* vestibulare rehabilitation in past 3 months\n* unusual physical activity the day of the posturography test\n* incapacity to understand the instruction, or to stand up the time of posturography without help\n* predictable incapacity to perform posturography in the time of the study\n\nExclusion criteria:\n\n* acute affliction that could affect the posturography test\n* daily physical activity modification due to medical advice or vestibular rehabilitation between two posturography'}, 'identificationModule': {'nctId': 'NCT05706051', 'acronym': 'Post-AP', 'briefTitle': 'Postural Modification and Hearing Aids in Presbycusis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Modification de la Posture et Appareillage Auditif Dans la Presbyacousie', 'orgStudyIdInfo': {'id': '2022-A02002-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'age-related hearing loss affected before hearing aid fitting', 'description': 'patients aged 55 to 80 years old, undergoing posturography at diagnosis of ARHL and 3 months later before hearing aid fitting, within the role of control\n\nsame patients udergoing posturography at hearing aid fitting and 3 months after.', 'interventionNames': ['Other: posturography']}], 'interventions': [{'name': 'posturography', 'type': 'OTHER', 'description': 'posturography will be performed when diagnosis of ARHL, in need of hearing aid fitting, is done and after information and written approval from patient. Posturography is performed later when hearing aid fitting and 3months after hearing aid use', 'armGroupLabels': ['age-related hearing loss affected before hearing aid fitting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'UH Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Le Mans', 'country': 'France', 'facility': "Dr Lorin's otholaryngology practice", 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Sophie Boucher, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'anonimized data within elliptic surface of posturography, PTA, and self reported dissiness'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}