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

Hearing Loss, Sensorineural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021132
• Other study ID #: RN-86132
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: August 2023
• Source: Aalborg University Hospital
• Contact: Jonas B Kjærsgaard, MD
• Phone: +45 96762735
• Email: jonas.kjaersgaard[@]rn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

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.

Locations

Country	Name	City	State
Denmark	Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.