CompletedNot Applicable

The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases

Turkey (Türkiye)45 participantsStarted 2025-03-01

Plain-language summary

This randomized controlled study compared the clinical and electrophysiological effectiveness of three vestibular rehabilitation approaches in patients with unilateral peripheral vestibular disease accompanied by otolith dysfunction: (1) traditional Cawthorne-Cooksey exercises (CCE), (2) two-dimensional (2D) otolith-targeted visual habituation, and (3) three-dimensional/virtual reality (3D/VR) otolith-targeted visual habituation. Forty-five patients aged 18-60 years were randomized into three groups and followed for 6 weeks. The Dizziness Handicap Inventory (DHI) was used as the primary clinical outcome, and cervical and ocular Vestibular Evoked Myogenic Potentials (cVEMP and oVEMP) were used as objective electrophysiological measures. Patients were monitored remotely using the Moodle learning management system.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Diagnosed unilateral peripheral vestibular disease No identified hearing loss (symmetric hearing) VEMP interaural asymmetry \>40% At least 3 months post-acute attack (chronic phase) No ocular disorders No cervical/physical problems No history of psychological or neurological disorders No regular use of alcohol or vestibular suppressant medications Non-fluctuating vestibular symptoms Exclusion Criteria: Additional balance disorder pathology beyond unilateral peripheral vestibular disease BPPV repositioning maneuver within the last 30 days Asymmetric or moderate-to-severe hearing loss Motion sickness Active BPPV symptoms in history

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change in Dizziness Handicap Inventory (DHI) total score

Timeframe: Baseline and 6 weeks post-intervention

Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Trial details

NCT IDNCT07606196

SponsorMedipol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-24

View on ClinicalTrials.gov More Vestibular Hypofunction trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean change in Dizziness Handicap Inventory (DHI) total score

Timeframe: Baseline and 6 weeks post-intervention

Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) P13 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Mean change in cervical Vestibular Evoked Myogenic Potential (cVEMP) N23 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) N10 wave latency

Timeframe: Baseline and 6 weeks post-intervention

Mean change in ocular Vestibular Evoked Myogenic Potential (oVEMP) P15 wave latency

Timeframe: Baseline and 6 weeks post-intervention