Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness

NCT07452653 | Not Yet Recruiting

• 1 other identifier: 303229
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

cochlear implantation; sensorineural hearing loss; vestibular hypofunction; vestibular weakness

Outcome Measures

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.

  From enrollment to 28 weeks after treatment

Secondary Outcomes (1)

• Peak slow-phase velocity

  From enrollment to 28 weeks after treatment

Study Arms (2)

Ipsilateral cochlear implantation to vestibular hypofunction

EXPERIMENTAL

Cochlear implantation on same side as ear with unilateral vestibular hypofunction

Procedure: Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction

Contralateral cochlear implantation to vestibular hypofunction

ACTIVE COMPARATOR

Cochlear implantation on opposite side as ear with unilateral vestibular hypofunction

Procedure: Contralateral cochlear implantation in patients with unilateral vestibular hypofunction

Interventions

Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction PROCEDURE

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.

Ipsilateral cochlear implantation to vestibular hypofunction

Contralateral cochlear implantation in patients with unilateral vestibular hypofunction PROCEDURE

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.

Contralateral cochlear implantation to vestibular hypofunction

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (5)

• Parmar A, Savage J, Wilkinson A, Hajioff D, Nunez DA, Robinson P. The role of vestibular caloric tests in cochlear implantation. Otolaryngol Head Neck Surg. 2012 Jul;147(1):127-31. doi: 10.1177/0194599812442059. Epub 2012 Mar 30.

  PMID: 22467287 BACKGROUND

• West N, Tian L, Vang Petersen LK, Bille M, Klokker M, Caye-Thomasen P. Objective Vestibular Test Battery and Patient Reported Outcomes in Cochlear Implant Recipients. Otol Neurotol. 2021 Apr 1;42(4):e416-e424. doi: 10.1097/MAO.0000000000002959.

  PMID: 33710994 BACKGROUND

• Rasmussen KMB, West N, Tian L, Caye-Thomasen P. Long-Term Vestibular Outcomes in Cochlear Implant Recipients. Front Neurol. 2021 Aug 11;12:686681. doi: 10.3389/fneur.2021.686681. eCollection 2021.

  PMID: 34456848 BACKGROUND

• Lovin BD, Gorelik D, Lin KF, Vrabec JT. Vestibular Hypofunction Screening in Older Cochlear Implant Candidates. Otolaryngol Head Neck Surg. 2024 Sep;171(3):858-863. doi: 10.1002/ohn.800. Epub 2024 Apr 30.

  PMID: 38686585 BACKGROUND

• Nayak N, Kellermeyer B, Dornton L, Heyd C, Kim CS, Wazen JJ. Vestibular dysfunction in cochlear implant candidates: Prevalence and outcomes. Am J Otolaryngol. 2022 Jan-Feb;43(1):103171. doi: 10.1016/j.amjoto.2021.103171. Epub 2021 Aug 6.

  PMID: 34509078 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin Lovin, MD

CONTACT

434-924-5700; "Lovin, Benjamin *HS" <YZA3EP@uvahealth.org>

Elena Squire

CONTACT

EM8ZK@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Otology & Neurotology, Department of Otolaryngology

Model Details: Randomization will be implemented to distribute subjects into the two research arms. The treatment arm is defined as the arm being implanted on the ipsilateral side with vestibular weakness while the control arm is defined as the arm being implanted on the contralateral side (the side without vestibular weakness). The subjects will be blinded to which arm they are assigned to during the consent process. They will undergo vestibular evaluation and if there is unilateral vestibular weakness, will be consented for the study. After they are consented, they will be randomized using a random number generator (1 or 2) to determine which arm they will be placed in. Subjects and the performing surgeon will know which ear is to be implanted prior to their cochlear implantation surgery.

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share