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

Phase

N/A

Condition

Hearing Loss

Hearing Impairment

Deafness

Treatment

cochlear implant

Clinical Study ID

NCT06021132

RN-86132

Ages > 18
All Genders

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 Criteria

Inclusion

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

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

Study Design