Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
NCT04869020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-07-17
Summary
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices. The study is designed to be conducted remotely using video conferencing between representatives of the manufacturer of the Otoband and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic there will be no person to person contact in the study.
Conditions
- Vertigo
Interventions
- DEVICE
-
Otoband
Participants with vertigo will wear the Otoband set at their chosen power level when experiencing symptoms.
- DEVICE
-
Sham A
Sham Device A is an OtoBand in which the transducer is modified so that the vibrations are not targeted at the vestibular system.
- DEVICE
-
Sham B
Sham Device B is an OtoBand that operates at power settings found to be nontherapeutic against vertigo associated with virtual reality.
Sponsors & Collaborators
-
Otolith Labs
lead INDUSTRY
Principal Investigators
-
Didier Depireux, PhD · OtolithLabs
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-19
- Primary Completion
- 2021-12-27
- Completion
- 2022-11-26
- FDA Device
- Yes
Countries
- United States
Study Locations
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