About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction
Procedure/SurgeryThis clinical trial is designed to elucidate the effects of cochlear implantation on the same or opposite side of the ear that demonstrates vestibular weakness in balance testing. This intervention will be used to perform cochlear implantation on the same side.
Contralateral cochlear implantation in patients with unilateral vestibular hypofunction
Procedure/SurgeryThis clinical trial is designed to elucidate the effects of cochlear implantation on the same or opposite side of the ear that demonstrates vestibular weakness in balance testing. This intervention will be used to perform cochlear implantation on the opposite side.
Treatment groups
Trial outcomes
Primary outcomes
Dizziness Handicap Inventory
The Dizziness Handicap Inventory (DHI) is composed of 25 questions under three categories of impact on disability with total scores greater than 10 points indicating some level of poor balance. The inventory is scored from 0 to 100, with higher scores indicating greater debilitating effect on life due to dizziness Pre-operative DHI scores will be assessed against post-operative DHI scores at 1st post-operative visit through paired t-testing. This will also be performed between pre-operative and post-operative DHI scores at the second post-operative visit.
Secondary outcomes
Peak slow-phase velocity
Secondary outcome variables include variables derived from VNG caloric testing. This is defined as the peak slow-phase velocity for each side (right or left) and for each temperature (warm or cold). These measures are also used to generate total response and unilateral paresis (a percentage)
Locations
Sponsors and contacts
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