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

Recruiting

• Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral

• Registration Number: NCT06021132
• Lead Sponsor: Aalborg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-26
• Study First Submitted QC: 2023-08-26
• Last Update Submitted: 2023-08-26
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2025-06-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark