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Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus

NCT04787653 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-22

No results posted yet for this study

Summary

This proposed study is a blinded study in which the participant will wear the OtoBand when their tinnitus is present to determine if the OtoBand reduces the perceived loudness of their tinnitus. The Study will be placebo controlled with each participant using an effective device for half of the enrollment period and a placebo device for half of the enrollment period. The order of placebo and effective usage will be randomized, and the researchers will be blinded to which device a participant is using. Study participants will be instructed in an online telehealth conference on how to operate the OtoBand and how to wear the OtoBand. Participants will be enrolled for approximately 30 days from Informed Consent to Wrap-up call.

Conditions

  • Tinnitus

Interventions

DEVICE

Otoband

Participants with Tinnitus will wear the Otoband set at an effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form.

DEVICE

Placebo

Participants with Tinnitus will wear the Otoband set at a non-effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form.

Sponsors & Collaborators

  • Otolith Labs

    lead INDUSTRY

Principal Investigators

  • Didier Depireux, PhD · Otolith Labs

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2024-01-31
Completion
2024-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787653 on ClinicalTrials.gov