OtoBand for Tinnitus

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

40 Participants Needed

Trial Summary

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.

Is OtoBand safe for treating tinnitus?

There is no specific safety data available for OtoBand in the provided research articles. However, the studies mention various acoustic therapies and drugs for tinnitus, but none specifically address the safety of OtoBand. ^{1 2 3 4 5}

How does the OtoBand treatment for tinnitus differ from other treatments?

The OtoBand treatment for tinnitus is unique because it likely involves a novel approach, potentially similar to electrical stimulation methods like the Audimax Theraband, which use inaudible, transdermal (through the skin) electrical stimulation to target tinnitus symptoms. This method differs from traditional treatments like oral medications or sound therapy, offering a non-invasive alternative that directly stimulates the auditory system. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests if the OtoBand, a wearable device, can reduce the loudness of tinnitus. It targets people with tinnitus and compares the effects of a real device to a non-active version. Participants will report any changes in their tinnitus loudness.

Research Team

Didier Depireux, PhD

Principal Investigator

Otolith Labs

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

An Electroencephalography-based Database for studying the Effects of Acoustic Therapies for Tinnitus Treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Acamprosate on Chronic Tinnitus: A Randomized-Controlled Trial. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[Analysis of reports of otoxicity, with symptoms of tinnitus, in the database of the Spanish Pharmacovigilance System for medicinal products for human use.] [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Pharmacological drugs inducing ototoxicity, vestibular symptoms and tinnitus: a reasoned and updated guide. [2014]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Drug-induced tinnitus and other hearing disorders. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with electrical stimulation: an evaluation of the Audimax Theraband. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of Gabapentin's Efficacy in Tinnitus Treatment: A Systematic Review. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Tinnitus-therapy by use of a tinnitus-masker (author's transl)]. [2006]

9. England pubmed.ncbi.nlm.nih.gov

Electrical tinnitus suppression: a double-blind crossover study. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A modified version of tinnitus retraining therapy: observing long-term outcome and predictors. [2018]