Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-31 @ 7:36 AM
Study NCT ID:
NCT05946395
Status:
WITHDRAWN
Last Update Posted:
2025-03-27
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly divided by drawing lots into 2 groups. Group A will benefit from speech therapy and synchronous equipment, and group B will begin speech therapy after 3 months after the installation of the equipment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The sponsor, in consultation with the coordinating investigator, decided to stop the study prematurely on 23/10/2024. Unfortunately, no patients were included in the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the Impact of Deafness in Adults', 'timeFrame': '3 months', 'description': 'Score of the questionnaire "Assessment of the Impact of Deafness in Adults" obtained at 3 months compared to the inclusion score.\n\nThe ERSA (Evaluation of the Repercussions of Deafness in Adults) assesses four areas: quality of life, personal life, social life and professional life. It is rated out of 200 or out of 150 in the absence of professional life. The higher the ERSA score, the better the patient\'s quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the score of the Evaluation of the Impact of Deafness in Adults(ERSA)/150 questionnaire obtained at 3 months compared to the inclusion score.', 'detailedDescription': 'This is a pilot, prospective, interventional, comparative, randomized, longitudinal, open, multicenter study comparing synchronous and delayed hearing aid and speech therapy.\n\nPatients will be randomly divided by drawing lots into 2 groups. Both groups will benefit from a hearing aid prescription and speech therapy for a series of 24 sessions at the rate of 1 per week, for an approximate duration of 6 months. Group A will benefit from speech therapy and synchronous equipment, and group B will begin speech therapy after 3 months after the installation of the equipment.\n\nRegarding the equipment, it will not be the same for all patients. Indeed, it is the one that will best suit the patient who will be chosen. The same will apply to the settings, in accordance with the usual support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, aged 65 to 80;\n* First equipment;\n* Average hearing loss between 40 and 70 db;\n* Speech comprehension greater than 50%;\n* Absence of acoustic recruitment phenomenon;\n* Symmetrical bilateral deafness (inter aural difference \\<20dB);\n* Affiliated patient or beneficiary of a social security scheme;\n* Patient speaking and understanding French, able to complete questionnaires and scales;\n* Patient having been informed and having signed an informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patient with a psychiatric pathology;\n* Patient with neurological disorders;\n* Patient taking psychotropic drugs;\n* Patient participating in another clinical study;\n* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;\n* Patient hospitalized without consent.'}, 'identificationModule': {'nctId': 'NCT05946395', 'acronym': 'CODITION', 'briefTitle': 'Comparison of Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Comparison of Synchronous or Delayed Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids', 'orgStudyIdInfo': {'id': '2022-A02788-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hearing aid and synchronous speech therapy', 'description': 'This arm will begin speech therapy at the same time as the fitting of the hearing aid.', 'interventionNames': ['Device: Hearing aid', 'Other: Speech therapy session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hearing aid and deferred speech therapy', 'description': 'This arm will begin speech therapy 3 months after fitting the device.', 'interventionNames': ['Device: Hearing aid', 'Other: Speech therapy session']}], 'interventions': [{'name': 'Hearing aid', 'type': 'DEVICE', 'description': 'Fitting a hearing aid', 'armGroupLabels': ['Hearing aid and deferred speech therapy', 'Hearing aid and synchronous speech therapy']}, {'name': 'Speech therapy session', 'type': 'OTHER', 'description': 'As speech therapy is part of standard care, the objective of the study will be to compare the impact of synchronous or delayed audioprosthetic and speech therapy care on the impact of deafness in elderly patients.', 'armGroupLabels': ['Hearing aid and deferred speech therapy', 'Hearing aid and synchronous speech therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'collaborators': [{'name': 'Euraxi Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}