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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cochlear implant | Device | Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech. |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated increase in speech audiometric performances | 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 | +24 months from last inclusion. Expected to be complete in juli 2025. |
| Anticipated increase in patient reported outcome measures | 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 | +24 months from last inclusion. Expected to be complete in juli 2025. |
| Test-retest assessment of vestibular screening battery | Double examination using commercial video head impulse test system and cervical vestibular evoked myogenic potentials. | Conducted before cochlear implantation in all patients. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult CI-candidates are to be included from our tertiary referral centre at the Audiological Department at Aalborg University Hospital, Aalborg, Denmark.
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| Name | Affiliation | Role |
|---|---|---|
| Jonas B Kjlærsgaard, MD | ENT department, Aalborg University Hospital | Principal Investigator |
| Michael L Gaihede, PhD, MD | ENT department, Aalborg University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital | Aalborg | 9000 | Denmark |
Full plan of analysis and raw data will be presented given there is still anonymity for the participants.
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |