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NCT04226976
Efficacy of a Non-invasive Vestibular System Masking for Improving Outcomes Following Acute Unilateral Vestibulopathy
NA trial testing Otoband in Dizziness in 40 participants. Suspended.
30 May 2024
Quick facts
| Lead sponsor | Otolith Labs |
|---|---|
| Phase | NA |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 June 2022 |
| Primary completion | 30 May 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Otoband
- Placebo Device
Conditions studied
Sponsor
Otolith Labs
Who can join
Adults 18 to 70, any sex, with Dizziness or Nausea. 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 and affect over 50% of the population over the age of 65 and a significant percentage of the younger population. Acute unilateral vestibulopathy (AUV) is easy to diagnose and is commonly treated with physical therapy exercises called vestibular rehabilitation. But due to the discomfort experienced during AUV, patients can't usually comply with the treatment plan prescribed by their healthcare provider. In this study, the investigators propose the use of an adjuvant device, the OtoBand, to improve balance, gait, reduce vertigo, and nausea in participants with AUV. Participants enrolled will undergo three vestibular tests batteries: one baseline, one with the OtoBand set at an effective power, and one with the placebo device set at low power. Neither participants nor investigator will know which device is effective and which is placebo. The OtoBand will be set at two different effective power levels. Which power level the participant will receive is randomized and unknown to the participant or investigator.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04226976
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of Otoband
Trials testing the same drug.
- 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
- NCT04787653 — Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus · NA · unknown
- NCT03996863 — Prevention of Unmitigated Chemotherapy-induced Emesis · NA · withdrawn
- NCT03886012 — Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo · NA · suspended
Other recruiting trials for Dizziness
Currently open trials in the same condition.
- NCT07225023 — A Multi-Site Feasibility Trial of Embedded Emergency Department Physical Therapy for Dizziness · NA · recruiting
- NCT06893029 — Dizziness Due to Visual Stimuli in Patients With Concussion and Other Causes of Dizziness: Examination of Balance Behavi · NA · recruiting
- NCT06704698 — Postoperative Analgesia Between Paravertebral Block and Epidural Block in Esophageal Surgery · NA · recruiting
- NCT06222450 — Vestibular Rehabilitation App for Adults With Dizziness Related to mTBI · NA · recruiting
- NCT07099222 — Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks · Phase 1, PHASE2 · active not 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
- 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
- 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 NCT04226976 (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: 22 March 2022
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/NCT04226976.
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