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NCT06267924
SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
NA trial testing Otoband Experimental in Vestibular Migraine in 322 participants. Completed in 8 January 2025.
9 December 2024
Quick facts
| Lead sponsor | Otolith Labs |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 322 |
| Start date | 6 March 2024 |
| Primary completion | 9 December 2024 |
| Estimated completion | 8 January 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Otoband Experimental
- Otoband Sham
Conditions studied
- Vestibular Migraine — all drugs for Vestibular Migraine →
- Migraine Associated Vertigo — all drugs for Migraine Associated Vertigo →
Sponsor
Otolith Labs
Who can join
Adults 18 to 75, any sex, with Vestibular Migraine or Migraine Associated Vertigo. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo. Participants will be: * Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device) * Randomized and stratified into groups based on the referring clinic to be assigned one study device * Asked to use the study device as instructed by the study coordinator * Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators * Asked to provide their vertigo diagnosis from their physician * Compensated for their participation Researchers will compare the randomized groups to determine which group responds better to which device.
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 NCT06267924
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Otoband Experimental
Trials testing the same drug.
- NCT05960786 — Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand · NA · completed
Other recruiting trials for Vestibular Migraine
Currently open trials in the same condition.
- NCT06992674 — The R-E-V-I-V-A-L Study · Phase 2 · active not recruiting
- NCT07518069 — Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes · recruiting
- NCT06540235 — The Effect of Bone-Conducted Stimulation on Rotary Chair Time Constants in Patients With Vestibular Migraines · NA · active not recruiting
- NCT05418218 — International Headache Registry Study · recruiting
- NCT04939922 — China Headache and Vertigo Registry Study · recruiting
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
- 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
- NCT04869020 — Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting · 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 NCT06267924 (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: 30 January 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/NCT06267924.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing