Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation

Study Overview
=================
Brief 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.

Official Title
-----------------
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation

Conditions
-----------------
Hearing Loss, Sensorineural, Hearing Loss, Bilateral

Intervention / Treatment
-----------------
* Device: cochlear implant


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cochlear implant, Residual hearing, Hearing preservation