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

Sponsor

Aalborg University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06021132

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural Hearing Loss, Bilateral	Device: cochlear implant

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Feb 28, 2026

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital	Aalborg		Denmark	9000

Sponsors and Collaborators

Aalborg University Hospital

Investigators

Principal Investigator: Jonas B Kjlærsgaard, MD, ENT department, Aalborg University Hospital
Study Director: Michael L Gaihede, PhD, MD, ENT department, Aalborg University Hospital