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

NCT06021132 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2025-10-07

No results posted yet for this 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.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Jonas B Kjlærsgaard, MD · ENT department, Aalborg University Hospital

  • Michael L Gaihede, PhD, MD · ENT department, Aalborg University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2027-06-01
Completion
2028-02-28
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06021132 on ClinicalTrials.gov