Assessing hearing and balance function in cochlear implant patients
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
This study is trying to see how cochlear implants affect hearing and balance in patients over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg) |
| Trial ID | NCT06021132 on ClinicalTrials.gov |
What this trial studies
This observational study will follow a group of patients undergoing cochlear implantation for two years to evaluate their hearing and vestibular function. Participants will undergo comprehensive assessments at multiple time points, measuring both subjective experiences through questionnaires and objective audiological tests. The study aims to correlate vestibular and audiological performance and test specific hypotheses using predefined statistical methods. The focus is on understanding the impact of cochlear implants on both hearing and balance.
Who should consider this trial
Good fit: Ideal candidates are adults with profound bilateral post-lingual hearing loss who are proficient in Danish and can commit to all study assessments.
Not a fit: Patients who have previously undergone cochlear implantation or have significant visual or neck mobility impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cochlear implants' effects on hearing and balance, leading to improved patient outcomes.
How similar studies have performed: While studies on cochlear implants are common, this specific focus on vestibular function alongside hearing outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aalborg
- Balance & Dizziness Centre, Department of Otolaryngology, Head & Neck Surgery and Audiology, Aalborg University Hospital — Aalborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Jonas B Kjlærsgaard, MD — ENT department, Aalborg University Hospital
- Study coordinator: Jonas B Kjærsgaard, MD
- Email: jonas.kjaersgaard@rn.dk
- Phone: +45 96762735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.