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

Last updated: August 26, 2023
Sponsor: Aalborg University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Deafness

Hearing Impairment

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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: cochlear implant
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
February 28, 2026

Connect with a study center

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

    Aalborg, 9000
    Denmark

    Active - Recruiting

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