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Behavioural Intervention

OtoBand for Tinnitus

N/A
Waitlist Available
Led By Didier Depireux, PhD
Research Sponsored by Otolith Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects age 18 to 70 years old
Tinnitus that is constant or predictable
Must not have
Taking benzodiazepines (e.g. clonazepam, lorazepam, diazepam)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up device use log over two week period of use by the study participant
Awards & highlights

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.

Who is the study for?
This trial is for people aged 18-70 with tinnitus lasting at least 90 days and a significant impact on their life, as measured by a specific questionnaire. Participants need internet access, an online payment account, and no recent skull surgery or implants. Those taking certain medications like benzodiazepines or with recent eye issues are excluded.Check my eligibility
What is being tested?
The study tests the OtoBand's effectiveness in reducing tinnitus loudness compared to a placebo. Participants will use both the real device and placebo at different times over about 30 days, not knowing which they're using when to ensure unbiased results.See study design
What are the potential side effects?
Since this trial involves a non-invasive device (OtoBand), side effects may be minimal but could include discomfort from wearing the device or potential psychological effects if participants perceive changes in their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I always have ringing in my ears or it happens in a pattern I can predict.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking benzodiazepines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~forms filled out daily over two week period by the study participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and forms filled out daily over two week period by the study participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
Secondary outcome measures
Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
Identification of a preferred power level for tinnitus as determined by Otoband device log.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Otoband efficacy on TinnitusActive Control1 Intervention
Participants will wear the Otoband on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Each participant will select his/her preferred stimulation level. The OtoBand will be programmed to operate at one of three power levels that are thought to be effective. The OtoBand will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form.
Group II: Placebo device efficacy on TinnitusPlacebo Group1 Intervention
The placebo device will use the same case, headband and battery as the OtoBand. The transducer in the OtoBand will be rotated 90 degrees, so that the placebo device will vibrate in a direction ineffectual at providing bone conducted vibrations. The vibrations will be in the horizontal plane, parallel to the skull, and will not have their energy penetrating the skull all the way to the vestibular system. Each participant will select his/her preferred stimulation level. The placebo devices will be made to vibrate at one of three power levels, none of which are thought to be effective. The placebo will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for tinnitus include sound therapy, cognitive behavioral therapy (CBT), and the use of devices like hearing aids or sound-masking devices. Sound therapy works by providing external noise to mask the internal sounds of tinnitus, thereby reducing its perceived loudness. CBT helps patients manage the emotional and psychological impact of tinnitus. Devices like the OtoBand aim to reduce the perceived loudness of tinnitus through neuromodulation, which alters nerve activity in the auditory pathways. Understanding these mechanisms is crucial for patients as it helps them choose the most effective treatment tailored to their specific symptoms and improves their quality of life.

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Who is running the clinical trial?

Otolith LabsLead Sponsor
9 Previous Clinical Trials
498 Total Patients Enrolled
Didier Depireux, PhDPrincipal InvestigatorOtolith Labs
5 Previous Clinical Trials
390 Total Patients Enrolled

Media Library

OtoBand (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04787653 — N/A
Tinnitus Research Study Groups: Otoband efficacy on Tinnitus, Placebo device efficacy on Tinnitus
~9 spots leftby Jul 2025
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