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

N/AActive Not RecruitingNCT06021132

Aalborg University Hospital39 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hearing Loss, Sensorineural Hearing Loss, Bilateral

Interventions

cochlear implant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: +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

Time frame: +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.

Time frame: Conducted before cochlear implantation in all patients.