Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear… (NCT06021132) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Denmark39 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anticipated increase in speech audiometric performances
Timeframe: +24 months from last inclusion. Expected to be complete in juli 2025.
2
Anticipated increase in patient reported outcome measures
Timeframe: +24 months from last inclusion. Expected to be complete in juli 2025.
3
Test-retest assessment of vestibular screening battery
Timeframe: Conducted before cochlear implantation in all patients.