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

NCT ID: NCT06021132

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2028-02-28

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.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonas Bruun Kjærsgaard

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas B Kjlærsgaard, MD

Role: PRINCIPAL_INVESTIGATOR

ENT department, Aalborg University Hospital

Michael L Gaihede, PhD, MD

Role: STUDY_DIRECTOR

ENT department, Aalborg University Hospital

Locations

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

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

RN-86132

Identifier Type: -

Identifier Source: org_study_id