Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-29 @ 9:51 AM
Study NCT ID:
NCT06021132
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2023-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D006312', 'term': 'Hearing Loss, Bilateral'}], 'ancestors': [{'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': 'D003054', 'term': 'Cochlear Implants'}], 'ancestors': [{'id': 'D058117', 'term': 'Neural Prostheses'}, {'id': 'D058542', 'term': 'Implantable Neurostimulators'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D006310', 'term': 'Hearing Aids'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2023-08-26', 'studyFirstSubmitQcDate': '2023-08-26', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anticipated increase in speech audiometric performances', 'timeFrame': '+24 months from last inclusion. Expected to be complete in juli 2025.', 'description': 'The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months'}, {'measure': 'Anticipated increase in patient reported outcome measures', 'timeFrame': '+24 months from last inclusion. Expected to be complete in juli 2025.', 'description': 'The preoperative status will be held against their performance at 6, 12 and 24 months. Yet the performance at 6 months will also be held against status at 24 months'}, {'measure': 'Test-retest assessment of vestibular screening battery', 'timeFrame': 'Conducted before cochlear implantation in all patients.', 'description': 'Double examination using commercial video head impulse test system and cervical vestibular evoked myogenic potentials.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cochlear implant', 'Residual hearing', 'Hearing preservation'], 'conditions': ['Hearing Loss, Sensorineural', 'Hearing Loss, Bilateral']}, 'descriptionModule': {'briefSummary': 'The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2 years, evaluating both subjective (patients reported) and objective outcomes over time. For the audiological part of the study both pure-tone and speech audiometry results will be held against the patient perceived benefit of the treatment as assessed by the questionnaires NCIQ and SSQ-12. The vestibular part of the study will evaluate the function of the SCCs and the sacculus. This is will be put in concert with functional tests of the vestibular system, and the patient perceived outcome measure DHI. Correlations between vestibular and audiological performances will be examined. A collection of specific hypotheses will be tested by predefined statistical methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult CI-candidates are to be included from our tertiary referral centre at the Audiological Department at Aalborg University Hospital, Aalborg, Denmark.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (At or above 18 years of age and capable of giving an informed consent)\n* Cochlear implant candidacy\n* Profound bilateral post-lingual hearing loss\n* Proficiency in Danish\n* Expected ability to participate on both all pre- and postoperative examinations\n* No previous CI experiences\n\nExclusion Criteria:\n\n* Later abandonment of CI candidacy\n* Blindness or visual handicap compromising eye movement evaluation\n* Distinct neck mobility handicap hindering either vHIT- or cVEMP examination\n* Patient reluctance, such as consistent no-show or cancellations of appointments\n* CI-surgery before preoperative evaluation could be obtained\n* Simultaneous bilateral cochlea implantation.\n* Sequential CI within the follow-up period'}, 'identificationModule': {'nctId': 'NCT06021132', 'briefTitle': 'Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation', 'orgStudyIdInfo': {'id': 'RN-86132'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cochlear implant', 'type': 'DEVICE', 'description': 'Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Jonas B Kjlærsgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ENT department, Aalborg University Hospital'}, {'name': 'Michael L Gaihede, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ENT department, Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Full plan of analysis and raw data will be presented given there is still anonymity for the participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jonas Bruun Kjærsgaard', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}