Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will test whether the OtoBand, a wearable device, can reduce the perceived loudness of tinnitus for people with the condition. The study will be placebo-controlled, meaning that some participants will use the OtoBand while others will use a similar-looking device that does not produce any sound. The researchers conducting the study will not know which participants are using the OtoBand and which are using the placebo, in order to avoid bias.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Device use log over two week period of use by the study participant
Device use log over two week period of use by the study participant
Identification of a preferred power level for tinnitus as determined by Otoband device log.
Forms filled out daily over two week period by the study participant
Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Otoband efficacy on Tinnitus
1 of 2
Placebo device efficacy on Tinnitus
1 of 2
Active Control
Non-Treatment Group
40 Total Participants · 2 Treatment Groups
Primary Treatment: Otoband efficacy on Tinnitus · Has Placebo Group · N/A
Placebo device efficacy on Tinnitus
Device
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DeviceOtoband efficacy on Tinnitus
Device
ActiveComparator Group · 1 Intervention: Otoband · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: device use log over two week period of use by the study participant
Who is running the clinical trial?
Otolith LabsLead Sponsor
7 Previous Clinical Trials
189 Total Patients Enrolled
Didier Depireux, PhDPrincipal InvestigatorOtolith Labs
3 Previous Clinical Trials
81 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Maryland | 33.3% |
| North Carolina | 16.7% |
| Florida | 16.7% |
| Other | 33.3% |
How old are they?
| 18 - 65 | 71.4% |
| 65+ | 28.6% |
What site did they apply to?
| OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/ | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 92.3% |
| Did not meet criteria | 7.7% |
Why did patients apply to this trial?
- "I have a hard case of tinnitus. It feels like I'm walking around with ear muffs on my head."
- "My life is held hostage by the noise in my head. Exposure to the high frequency noises of the city makes it worse so I am virtually a prisoner of my home."
What questions have other patients asked about this trial?
- "Is this Washington state or DC?"
- "How long do the screening visits take?"
How many prior treatments have patients received?
| 2 | 66.7% |
| 3+ | 33.3% |
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