Status:

UNKNOWN

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

Lead Sponsor:

Otolith Labs

Conditions:

Tinnitus

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief 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 S...

Detailed Description

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 remotely using video conferencing between rep...

Eligibility Criteria

Inclusion

  • Male or female subjects age 18 to 70 years old
  • Tinnitus that has been present for at least 90 days
  • Tinnitus that is constant or predictable
  • Computer and access to internet for online video conference
  • Score greater than or equal to 36 on the Tinnitus Handicap Questionnaire
  • Access to a PayPal, Venmo account to receive compensation

Exclusion

  • Tinnitus that first presented within the last 90 days
  • Tinnitus Handicap Questionnaire of 29 or less
  • Skull base surgery within the last 90 days
  • Any skull implant (cochlear implant, bone conduction implant, DBS)
  • No history of vitreous detachment in the last 60 days (no new floaters or unexplained flashes of light in the eye)
  • Taking benzodiazepines (e.g. clonazepam, lorazepam, diazepam) Participant reports that their tinnitus is caused by a medication they are taking

Key Trial Info

Start Date :

March 5 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 28 2024

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04787653

Start Date

March 5 2021

End Date

February 28 2024

Last Update

March 22 2022

Active Locations (1)

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1

OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/

Washington D.C., District of Columbia, United States, 20009