cochlear implant: Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults (At or above 18 years of age and capable of giving an informed consent)
* Cochlear implant candidacy
* Profound bilateral post-lingual hearing loss
* Proficiency in Danish
* Expected ability to participate on both all pre- and postoperative examinations
* No previous CI experiences
Exclusion Criteria:
* Later abandonment of CI candidacy
* Blindness or visual handicap compromising eye movement evaluation
* Distinct neck mobility handicap hindering either vHIT- or cVEMP examination
* Patient reluctance, such as consistent no-show or cancellations of appointments
* CI-surgery before preoperative evaluation could be obtained
* Simultaneous bilateral cochlea implantation.
* Sequential CI within the follow-up period
Primary outcome measure(s)
Anticipated increase in speech audiometric performances — +24 months from last inclusion. Expected to be complete in juli 2025. 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
Anticipated increase in patient reported outcome measures — +24 months from last inclusion. Expected to be complete in juli 2025. 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
Test-retest assessment of vestibular screening battery — Conducted before cochlear implantation in all patients. Double examination using commercial video head impulse test system and cervical vestibular evoked myogenic potentials.
Trial sites (1)
Facility
City
Region
Status
Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
Aalborg
Denmark
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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