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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cochlear Implant

Device

Insertion of a electrode into the cochlear with the aim of providing deaf and severe hearing handicapped with the ability to hear speech.

Primary outcomes

Anticipated increase in speech audiometric performances

Time frame: +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

Time frame: +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
Test-retest assessment of vestibular screening battery

Time frame: Conducted before cochlear implantation in all patients.

Double examination using commercial video head impulse test system and cervical vestibular evoked myogenic potentials.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2028
First posted: Sep 1, 2023
Registry last updated: Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting