OtoBand for Tinnitus

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Otolith Labs

Must not be taking: Benzodiazepines

Disqualifiers: Recent skull surgery, Skull implants, others

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the OtoBand can reduce the loudness of tinnitus, a condition characterized by ringing or buzzing in the ears. Participants will wear two different headbands: one potentially effective and a placebo. Researchers will compare the effects of both to assess the OtoBand's efficacy. Individuals with constant or predictable tinnitus for at least 90 days who can join online video calls may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding tinnitus treatment options.

Will I have to stop taking my current medications?

The trial requires that you do not take benzodiazepines (a type of medication often used for anxiety or sleep) and that your tinnitus is not caused by any medication you are currently taking.

What prior data suggests that the OtoBand is safe for tinnitus treatment?

Research shows that specific safety information for the OtoBand as a treatment for tinnitus is not yet available. The trial's "Not Applicable" phase designation likely indicates ongoing safety studies. This makes it challenging to provide clear safety evidence at this time. As the OtoBand remains under testing, participants should be aware that its safety is still under review. This consideration is important when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

While most treatments for tinnitus focus on masking the noise or using medications to manage the symptoms, the OtoBand offers a new approach by using bone conduction technology. This device is worn on the mastoid bone behind the ear and aims to directly influence the auditory pathways through targeted vibrations. Researchers are excited about the OtoBand because it provides a non-invasive, personalized treatment option that allows users to select their preferred stimulation level, potentially offering quicker relief. Unlike typical methods, which can be slow-acting or come with side effects, the OtoBand promises a user-friendly experience that targets the problem in a novel way.

What evidence suggests that the OtoBand is effective for tinnitus?

Research shows that the OtoBand might reduce the loudness of tinnitus. In earlier studies, people who used the OtoBand reported improvements in their tinnitus symptoms. The device sends vibrations to the skull, potentially altering how the brain perceives sounds. Early results suggest this could be effective, but more information is needed for confirmation. This trial compares the OtoBand to a placebo device to verify the effects. Participants in past studies demonstrated positive results, making it an intriguing option for tinnitus relief. ^{1 2 3 6 7}

Who Is on the Research Team?

Didier Depireux, PhD

Principal Investigator

Otolith Labs

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a score of 36 or higher on the Tinnitus Handicap Questionnaire.

Access to a computer and internet for online video conference

I have had ringing in my ears for at least 3 months.

Exclusion Criteria

I am currently taking benzodiazepines.

I have not had skull base surgery in the last 3 months.

My ringing in the ears started within the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants use the OtoBand and placebo device to assess tinnitus loudness reduction

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• OtoBand
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Otoband efficacy on Tinnitus Active Control 1 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 Tinnitus Placebo Group 1 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.

Who Is Running the Clinical Trial?

Otolith Labs

Lead Sponsor

Trials

11

Recruited

700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04787653

Evaluation of the OtoBand as a Treatment to Reduce ... This study seeks to gather data on the effect of the OtoBand in participants who have reported symptoms of tinnitus. The study is designed to be conducted ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04787653?term=tinnitus&draw=2&rank=5

Evaluation of the OtoBand as a Treatment to Reduce ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. withpower.com withpower.com/trial/phase-tinnitus-2-2021-49a4a

OtoBand for Tinnitus · Info for Participants Trial Overview The study tests the OtoBand's effectiveness in reducing tinnitus loudness compared to a placebo. Participants will use both the real device and ...

4. trial.medpath.com trial.medpath.com/clinical-trial/62c51f02c216a811/nct04787653-evaluation-otoband-treatment-reduce-tinnitus-loudness

Evaluation of the OtoBand as a Treatment to Reduce the ... This study seeks to gather data on the effect of the OtoBand in participants who have reported symptoms of tinnitus. The study is designed to be conducted ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12575424/

Digital Therapeutics in Tinnitus Care: A Feasibility Study of ... Use of Oto in managing tinnitus was demonstrated to be deliverable and feasible with a high retention rate. A large-scale randomized controlled trial is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10620247/

A randomized, double-blind, placebo-controlled phase 2 study ... OTO-313 did not demonstrate a significant treatment benefit relative to placebo due in part to a high placebo response. OTO-313 was safe and well-tolerated.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8584222/

Intratympanic Administration of OTO-313 Reduces Tinnitus in ... Safety data were collected at all visits and included collection and evaluation of treatment-emergent adverse events, vital signs, clinical laboratory ...