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Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness

NCT07452653 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-10

No results posted yet for this study

Summary

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.

Conditions

  • Sensorineural Hearing Loss
  • Vestibular Hypofunction

Interventions

PROCEDURE

Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction

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.

PROCEDURE

Contralateral cochlear implantation in patients with unilateral vestibular hypofunction

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.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452653 on ClinicalTrials.gov