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Sensorineural Hearing LossNCT07452653

Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness

A study testing Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction and Contralateral cochlear implantation in patients with unilateral vestibular hypofunction in people with Sensorineural Hearing Loss and Vestibular Hypofunction, run by University of Virginia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction and Contralateral cochlear implantation in patients with unilateral vestibular hypofunction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Apr 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Fetuses, neonates, children
  • Prisoners
  • Cognitively impaired adults

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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.

Read the detailed description

As the global population continues to age, there is a growing prevalence rate of hearing loss associated with increased rates of physical disability and falls. After the Centers for Medicare and Medicaid Service (CMS) recently expanded the candidacy profile for cochlear implantation to include a lower threshold for hearing test scores, more patients with hearing loss now have the option to pursue cochlear implantation. Cochlear implantation is widely regarded to be a relatively safe procedure due to its minimally invasive nature and low rate of complications. However, surgical manipulation of the labyrinth presents a risk of potential damage to the vestibular structures of the inner ear. One of the most common complications of cochlear implantation is post-operative vestibular weakness, measured to be 16-30%. Vestibular weakness presenting as vertigo or dizziness is of greater risk to the aging population as it is a contributor to falls as well as poor quality of life.

In planning for cochlear implantation in patients with bilateral symmetric hearing loss, the choice of which ear to implant is based on physician and patient discretion. Apart from relative contraindications such as the presence of pathology within the ear canal or middle ear on one side, there are few delineating factors that provide clear decision-making with regard to laterality selection. At present, many surgeons simply let the patient decide which ear they prefer. Reducing potential post-operative complications such as vestibular symptoms presents one potential avenue for guidance on ear selection. In patients who have pre-existing unilateral vestibular weakness, it may be important to preserve vestibular function on the contralateral side in hopes of avoiding bilateral vestibular hypofunction after implantation; however, there is scant knowledge to inform surgeons on how pre-existing vestibular weakness could or should affect laterality selection in cochlear implantation and whether it has measurable impact on patients' course after surgery.

There is a scarcity of prospective research assessing how to optimize patients with vestibular weakness who are undergoing cochlear implantation. West et al. conducted a prospective observational trial assessing the impact of cochlear implantation on vestibular function through pre- and post-operative vestibular testing. They found that the ear implanted demonstrated worsened vestibular function after the procedure without an association with self-reported symptoms. A separate prospective observational study led by Rasmussen et al. also investigated the relationship between vestibular function and cochlear implantation and found decreased vestibular function on the implanted side. Although both studies considered patients with bilateral hearing loss, they did not introduce control for surgical laterality in patients with unilateral weakness. A retrospective study conducted by Lovin et al. focused on patients who had undergone videonystagmography testing in helping to select laterality. Of the 27 patients who were bilateral candidates for cochlear implantation, decision-making involving the impact of pre-existing vestibular hypofunction resulted in the alteration of treatment plans for four patients. Parmar et al. retrospectively evaluated patients who received cochlear implants and had pre-operative VNG testing. They did not find a difference in post-operative Dizziness Handicap Inventory (DHI) scores between those who had implantation in the ear with better vestibular function compared to those who were implanted on the contralateral side; however, this was limited by retrospective design, lack of pre-operative DHI scores, and, most importantly, that not all patients had to demonstrate unilateral vestibular weakness for inclusion. Finally, Nayak et al. published subset data on patients with vestibular hypofunction who received implantation ipsilateral and contralateral to the hypofunction. They did not find a difference in rates of subjective dizziness at 1 month post-operatively but again were limited by lack of pre-operative dizzy information and use of validated questionnaires.

The investigators hope to expand on the works of these studies with a prospective randomized control trial to better elucidate how to risk-stratify similar patients. Determining an accurate sample size through power analysis is not possible for this study at this time due to the lack of prior usable literature or data in determining effect size. The results from this pilot study will be used to generate a comprehensive power analysis for future studies dedicated to this topic.

Being tested
Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction, Contralateral cochlear implantation in patients with unilateral vestibular hypofunction
Keywords
cochlear implantation, sensorineural hearing loss, vestibular hypofunction, vestibular weakness
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunctionProcedure or 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 hypofunctionProcedure or 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.

Study groups in NCT07452653
Study groupRoleWhat they receive
Ipsilateral cochlear implantation to vestibular hypofunctionExperimentalCochlear implantation on same side as ear with unilateral vestibular hypofunction
Receives: Procedure: Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction
Contralateral cochlear implantation to vestibular hypofunctionActive comparatorCochlear implantation on opposite side as ear with unilateral vestibular hypofunction
Receives: Procedure: Contralateral cochlear implantation in patients with unilateral vestibular hypofunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to 28 weeks after treatment

Secondary outcomes (1)
  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)

    Measured: From enrollment to 28 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07452653
Sponsor's protocol ID
303229
Status last verified
Mar 2026
First submitted
28 Feb 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This will be a pilot study with limited data

Publications

  • 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.

    PubMed 22467287
  • 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.

    PubMed 33710994
  • 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.

    PubMed 34456848
  • 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.

    PubMed 38686585
  • 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.

    PubMed 34509078

Questions about this trial

What is this clinical trial studying?

A study testing Ipsilateral cochlear implantation in patients with unilateral vestibular hypofunction and Contralateral cochlear implantation in patients with unilateral vestibular hypofunction in people with Sensorineural Hearing Loss and Vestibular Hypofunction, run by University of Virginia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Benjamin Lovin, MD (434-924-5700, "Lovin, Benjamin *HS" <YZA3EP@uvahealth.org>), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dizziness Handicap Inventory (time frame: From enrollment to 28 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07452653, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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