NCT06021132

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2027-06-01
• Completion: 2028-02-28
• First posted: 2023-09-01
• Last updated: 2025-10-07

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study