Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT05325450
Status:
UNKNOWN
Last Update Posted:
2023-08-24
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Hearing Performance in the Subject Implanted
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D003638', 'term': 'Deafness'}], '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': 'D016344', 'term': 'Medicare Part A'}], 'ancestors': [{'id': 'D006278', 'term': 'Medicare'}, {'id': 'D008483', 'term': 'Medical Assistance'}, {'id': 'D011632', 'term': 'Public Assistance'}, {'id': 'D005380', 'term': 'Financing, Government'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D007878', 'term': 'Legislation as Topic'}, {'id': 'D012926', 'term': 'Social Control, Formal'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'two within-subject crossover experiments (short-term and long-term) where each subject will follow two phases of the protocol (training A and training B).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-22', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is the percentage of correct speech recognition after training between the two training programs', 'timeFrame': 'Month 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['deafness, cochlear implant'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': 'In the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (CI) candidates have significant residual hearing in their contralateral ear. However, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. The present project aims to better understand the mechanisms of perceptual learning of CI-processed speech after implantation and to develop and test rehabilitation strategies for CI users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18\n* Unilaterally postlingually-deafened adult cochlear implanted candidates (IC-Uni)\n* Person with almost normal or moderate contralateral hearing ( under 60dB)\n* Cochlear implanted person whose activation has not yet been performed\n* Cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant\n* Affiliated to social security\n\nExclusion Criteria:\n\n* \\- Subjects under juridical protections or tutelage measure\n* Subjects with associated neurological or neurodegenerative conditions\n* Significant anatomical changes on CT scan of the temporal bone that may interfere with the insertion of the cochlear implant'}, 'identificationModule': {'nctId': 'NCT05325450', 'acronym': 'OPERSA', 'briefTitle': 'Optimization of Hearing Performance in the Subject Implanted', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Optimization of Hearing Performance in the Subject Implanted With Profound Asymmetric Deafness', 'orgStudyIdInfo': {'id': 'RC31/21/0125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training A', 'description': 'Training A in Unilaterally postlingually-deafened adult cochlear implanted candidates', 'interventionNames': ['Procedure: Program A']}, {'type': 'EXPERIMENTAL', 'label': 'Training B', 'description': 'Training B in Unilaterally postlingually-deafened adult cochlear implanted candidates', 'interventionNames': ['Procedure: Program B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Training in bilaterally postlingually-deafened adult cochlear implanted candidates', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Program A', 'type': 'PROCEDURE', 'description': 'Presentation of the sentence to the implant alone', 'armGroupLabels': ['Training A']}, {'name': 'Program B', 'type': 'PROCEDURE', 'description': 'Presentation of the sentence to the implanted ear, associated for the non-implanted ear', 'armGroupLabels': ['Training B']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Presentation of the sentences alternately to the most recently implanted ear and both implanted ears at the same time', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Marx', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Mathieu MARX', 'role': 'CONTACT', 'email': 'marx.m@chu-toulouse.fr', 'phone': '0561777704'}, {'name': 'Nadege ALGANS', 'role': 'CONTACT', 'email': 'algans.n@chu-toulouse.fr', 'phone': '0561777204'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}