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

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Intervention / Treatment: Device: cochlear implant

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Jonas B Kjærsgaard, MD; Phone Number: +45 96762735; Email: jonas.kjaersgaard@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital
    • Contact: Jonas B Kjærsgaard, MD
    • Contact: Michael L Gaihede, PhD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult CI-candidates are to be included from our tertiary referral centre at the Audiological Department at Aalborg University Hospital, Aalborg, Denmark.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticipated increase in speech audiometric performances	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	+24 months from last inclusion. Expected to be complete in juli 2025.
Anticipated increase in patient reported outcome measures	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	+24 months from last inclusion. Expected to be complete in juli 2025.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: August 26, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Cochlear implant; Residual hearing; Hearing preservation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
• Other Study ID Numbers: RN-86132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Full plan of analysis and raw data will be presented given there is still anonymity for the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No