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NCT03618199
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
NA trial testing Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing in Vestibular Function Tests in 39 participants. Completed in 22 August 2022.
22 August 2022
Quick facts
| Lead sponsor | Otolith Labs |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 39 |
| Start date | 1 October 2018 |
| Primary completion | 22 August 2022 |
| Estimated completion | 22 August 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing
Conditions studied
- Vestibular Function Tests — all drugs for Vestibular Function Tests →
- Dizziness — all drugs for Dizziness →
Sponsor
Otolith Labs
Who can join
Adults 18 to 65, any sex, with Vestibular Function Tests or Dizziness. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vestibular disorders are among the most common causes of disability in society. Vestibular dysfunction affects over one third of the population over the age of 40 and a significant percentage of the younger population. Vestibular disorders have a dramatic impact on daily life impacting work, relationships, and even activities of daily living. Diagnosis of vestibular disorders is often facilitated by functional vestibular tests. The most common of these tests is videonystagmography, during a critical portion of which, the "caloric test," warm and cool stimuli are presented in the outer ears to stimulate the inner ear vestibular system. The vertigo produced by caloric stimulation not uncommonly results in nausea, and sometimes vomiting, sometimes to the point of not being able to complete the test protocol. In this project we examine a device that has shown promise and might be beneficial for improving the testing for vestibular disorders. We hypothesize that with this device, the nausea associated with caloric testing will be significantly reduced when the device is used, while it will not change the results of the test in a statistically significantly manner. To date, the device has only been systematically tested on healthy volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03618199
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Related trials
Other Otolith Labs trials
Trials by the same sponsor.
- NCT06540235 — The Effect of Bone-Conducted Stimulation on Rotary Chair Time Constants in Patients With Vestibular Migraines · NA · active not recruiting
- NCT06267924 — SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines · NA · completed
- NCT05960786 — Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand · NA · completed
- NCT04226976 — Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy · NA · suspended
- NCT05157399 — Quantification of the Effect of the OtoBand on Objective Measures of Vertigo and Dizziness · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03618199 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Otolith Labs
- Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03618199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing