Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
Launched by AALBORG UNIVERSITY HOSPITAL · Aug 26, 2023
Trial Information
Current as of May 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how cochlear implants (devices that help improve hearing) affect both hearing and balance in adults with severe hearing loss. The researchers will follow participants for two years after their surgery, checking their hearing abilities and balance regularly. They will gather information from the patients themselves about how they feel and any benefits they notice from the treatment, as well as perform specific tests to measure hearing and balance functions.
To be eligible for this trial, participants must be adults aged 18 or older who have profound hearing loss in both ears and are suitable candidates for cochlear implants. They should speak Danish and be able to attend all scheduled evaluations before and after the surgery. It’s important to note that participants should not have had any previous cochlear implant surgeries. Throughout the trial, they can expect a comprehensive assessment of their hearing and balance, helping researchers understand how these two functions relate and improve with cochlear implants.
Gender
ALL
Eligibility 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
About Aalborg University Hospital
Aalborg University Hospital is a leading healthcare institution in Denmark, renowned for its commitment to advancing medical research and patient care. As a prominent clinical trial sponsor, the hospital actively engages in innovative studies aimed at improving health outcomes across various medical disciplines. With a focus on collaboration and interdisciplinary approaches, Aalborg University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous clinical trials, ensuring adherence to the highest ethical standards and regulatory requirements. The institution is dedicated to fostering a culture of research excellence, contributing valuable insights to the medical community and enhancing treatment options for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aalborg, , Denmark
Patients applied
Trial Officials
Jonas B Kjlærsgaard, MD
Principal Investigator
ENT department, Aalborg University Hospital
Michael L Gaihede, PhD, MD
Study Director
ENT department, Aalborg University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported