Cochlear implants for patients undergoing vestibular schwannoma removal or labyrinthectomy
Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease
NA · Ohio State University · NCT03795675
This study is testing if cochlear implants can help people who are having surgery for vestibular schwannoma or labyrinthectomy due to Meniere's disease hear better after they lose hearing on one side.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ohio State University (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03795675 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the safety and effectiveness of cochlear implants in patients who are undergoing surgery for vestibular schwannoma or labyrinthectomy due to Meniere's disease. Participants will receive a cochlear implant after their surgical procedure, as they will experience deafness on the surgical side. The study will assess the outcomes of these implants over time, particularly focusing on speech perception and overall auditory function. This approach represents a new application of an already approved device for a specific patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with vestibular schwannoma or Meniere's disease who are scheduled for surgery and can have their auditory nerve preserved.
Not a fit: Patients with bilateral vestibular schwannomas or Meniere's disease, or those unable to preserve the auditory nerve during surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with single-sided hearing loss following specific surgical procedures.
How similar studies have performed: While cochlear implants are commonly used for bilateral hearing loss, this specific application for patients undergoing these surgeries is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician * Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy * Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences * For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve Exclusion Criteria: * Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas * Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma * Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation * Active middle ear disease * Greater than 70 years of age * Vestibular schwannoma greater than 2 cm * Patient refusal of receiving pneumococcal vaccine * Any contra-indication(s) for undergoing surgery.
Where this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Oliver Adunka, MD — Ohio State University
- Study coordinator: Meghan Hiss, AuD
- Email: Meghan.Hiss@osumc.edu
- Phone: 614-366-1549
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.
Conditions: Vestibular Schwannoma, Meniere Disease, Cochlear implants