Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness
Starting soon · Not applicable
Conditions studied: Sensorineural Hearing Loss, Vestibular Hypofunction
In brief
In patients with symmetric hearing loss who meet traditional cochlear implant candidacy criteria yet demonstrate pre-operative unilateral vestibular weakness, the choice of which ear to implant may impact their post-operative vestibular course. The investigators aim to implement both objective videonystagmography metrics as well as subjective patient-reported outcome measures to assess whether selecting laterality for cochlear implantation as it relates to unilateral vestibular loss has a measurable impact on patients' post-operative vestibular function. In pursuing cochlear implantation on the ear that demonstrates worse vestibular function, the investigators hypothesize improved vestibular function in comparison to operating on the unaffected side. The randomized control pilot study plans to allocate 10 subjects to a treatment group that involves cochlear implantation on the ipsilateral side of vestibular hypofunction and a control group that will undergo implantation on the contralateral side. The investigators plan to compare scores derived from the Dizziness Handicap Inventory completed at pre-operative evaluation and at two subsequent post-operative visits between control and treatment groups as primary outcome. The investigators also plan to determine if there is a significant difference in measures derived from caloric vestibular testing pre- and post-operatively as well as between control and treatment groups.
Key facts
- Study ID
- NCT07452653
- Run by
- University of Virginia
- People needed
- 10
- Starts
- 2026-04-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-03-10
Who can join
Age: 50 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients over the age of 50 years
- Bilateral and symmetric moderate to profound sensorineural hearing loss (SNHL). Symmetric SNHL will be defined objectively as no more than 20dB difference at any 2 consecutive frequencies or no more than 15dB difference at any 3 consecutive frequencies on standard audiometry and as no significant difference between the ears to the patient.
- Unilateral vestibular weakness. Unilateral vestibular weakness will be defined by caloric testing of a greater than 22% difference between ears using bithermal water irrigation.
- Candidates for cochlear implantation by meeting traditional cochlear implant audiometric criteria.
- Willingness and ability to comply with scheduled visits and study procedures.
You may not qualify if…
- Patients with prior unilateral cochlear implantation
- Asymmetric SNHL
- Absence of unilateral vestibular weakness
- Contraindication for caloric testing (including epilepsy, dysconjugate eye movements, and history of ear or eye surgery less than 2 months prior)
- Alternative reasons for selecting cochlear implant laterality, including external. middle, or inner ear disease, anatomical abnormalities, or retrocochlear pathology
- Pregnant women
- Fetuses, neonates, children
- Prisoners
- Cognitively impaired adults
Full record on ClinicalTrials.gov
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