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

Aalborg University Hospital

Status: Active, not recruiting

Conditions: Hearing Loss, Bilateral; Hearing Loss, Sensorineural

Treatments: Device: cochlear implant

Study type: Observational

Funder types: Other

Identifiers

NCT06021132

RN-86132

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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