An interventional study of Otoband Experimental and Otoband Sham in Vertigo, BPPV and Meniere Disease, sponsored by Otolith Labs. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Otolith Labs · Not applicable, Interventional, and Treatment
The goal of this virtual clinical trial is to determine the effectiveness of two study devices in providing temporary relief to adults aged 18-70 who suffer from symptoms of chronic vestibular vertigo.
The main question[s] it aims to answer are:
Participants will be:
Researchers will compare the randomized groups to see which groups respond better to which device.
This study is decentralized clinical trial. This study uses technology and and virtual meetings to communicate with study participants and collect study data. This study seeks to enroll until 36 participants in the Moderate or Worse (MoW) arm have completed the study, and until 72 participants have completed the Quality of Life (QoL) arm.
All study participants that meet all of the inclusion, none of the exclusion criteria, and sign informed consent will be enrolled in the study. Participants will complete a one day enrollment meeting and an approximately 14 day Baseline Phase.
After the Baseline Phase, participants will be placed in one of two groups Moderate or Worse (MoW) group or Quality of Life (QoL) group based on the data collected about their vertigo during the Baseline Phase.
Participants will then be randomized within their assigned group (MoW or QoL) at a 2:1 ratio to an active arm or sham arm to begin the Treatment Phase of the study. Participants will be sent a study device to use when they have a vertigo episode.
Participants that enroll in the study are expected to participate up to 49 days with virtual meetings at the approximate intervals:
MoW Group: Day 4, Day 16, Day 21, Day 24, Day 31, and Day 42 QoL Group : Day 4, Day 16, Day, 21, Day 24, Day 31, and Day 49
Participants will be required to complete the DHI (Dizziness Handicap Index), VSS (Vertigo Symptom Scale), Global Impression of Symptoms, and Global Impression of Change questionnaires.
Otolith Labs received Therapeutic Breakthrough Device designation by the FDA in May 2021.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's enrollment of 109 is above the median of 57 across 186 interventional studies indexed under Vertigo.
Browse Vertigo studies →Otolith Labs is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be eligible to participate in this study, an individual must meet all the following criteria:
Diagnosed as having vestibular vertigo that is caused by one or more of:
Exclusion Criteria:
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.
Device: Otoband Experimental
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.
Device: Otoband Sham
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the experimental device.
Device: Otoband Experimental
Participants will be randomized to use the Otoband as instructed by clinical coordinator per study protocol. There are 4 power levels, these participants will receive the sham device.
Device: Otoband Sham
Participants will be randomly assigned to use the Otoband to determine effectiveness in providing temporary relief to symptoms of vertigo.
Participants will be randomly assigned to use the Otoband sham to determine effectiveness in providing temporary relief to symptoms of vertigo.
Moderate or Worse Change in Vertigo Severity
Change in participant response to "How severe is your vertigo right now?" during vertigo episodes, compared to responses in baseline phase
Time frame: Through 21 days of treatment phase of "moderate of worse" arm of study
Quality of Life Change in Scores
Change in participant's Vertigo Symptom Scale (VSS) score, compared to baseline VSS score
Time frame: Day 28 of treatment phase of "quality of life" arm of study
Device Effectiveness
Percent change in mean severity of vertigo episodes as reported by the participant during the Treatment phase, compared to the Baseline phase.
Time frame: 30 minutes post vertigo episode during the treatment phase
Effectiveness of Rating Scales
Comparison of Verbal Rating Scale vs. Numerical Rating Scale as representation of participant response to device treatment.
Time frame: Through 21 days of treatment phase of "moderate of worse" arm of study
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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