Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorUniversity of Virginia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction

    Procedure/Surgery

    This 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/Surgery

    This 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

10 Participants
are divided into 2 treatment groups
Group A: Ipsilateral cochlear implantation to vestibular hypofunctionExperimental treatment 1 intervention
Group B: Contralateral cochlear implantation to vestibular hypofunctionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 28 weeks after treatment

Secondary outcomes

1

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)

Time frame
From enrollment to 28 weeks after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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