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

Primary Purpose

Tinnitus

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Otoband
Placebo
Sponsored by
Otolith Labs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tinnitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Otoband efficacy on Tinnitus

Placebo device efficacy on Tinnitus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
The primary endpoint will be the change in THQ score of a participant while wearing an effective device versus the THQ score at enrollment/baseline.

Secondary Outcome Measures

Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
Change in Quality of Life Measures at the conclusion of the study versus the start of enrollment as measured by the Tinnitus Handicap Questionnaire.
Identification of a preferred power level for tinnitus as determined by Otoband device log.
Identification of a preferred power level for tinnitus as determined by the power level that participants use for the longest cumulative use throughout the study.

Full Information

First Posted
February 9, 2021
Last Updated
March 21, 2022
Sponsor
Otolith Labs
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1. Study Identification

Unique Protocol Identification Number
NCT04787653
Brief Title
Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
Official Title
Evaluation of the OtoBand as a Treatment to Reduce the Perceived Loudness of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otolith Labs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 representatives of the manufacturer of the OtoBand and participants. In order to comply with requirements for non-essential contact due to the Covid-19 pandemic, there will be no in-person contact in the study. Otolith Sound (hereafter: "Otolith") seeks to recruit study participants via several online channels including Facebook, Google and their website https://otolithlabs.com/tinnitustelehealthstudy/ . Otolith will use online advertisements to inform potential participants about the study and ask them to volunteer for online screening and enrollment. Each participant will be enrolled in the study only after a successful video screening including agreement to participate. After a participant is enrolled, a device will be shipped to them via USPS or similar carrier. The participant will be instructed not to open the shipping box with the device until their initial study call with the study coordinator. During the initial study call, participants will be instructed on how to use the OtoBand and how to wear the device. There will be a total of four online meetings with each study participant. It is expected that a typical participant will be enrolled in the study for approximately 30 days - from consent to filling out the last questionnaire and online wrap up meeting. In these 30 days, the participant will be wearing a device for 30 minutes each day over the course of two times 5 days. In addition to online study calls, Sponsor will use email and text messaging to communicate with the participants. For example, if a study participant does not complete a study diary on a given day, a text message will be sent reminding them to do so. After the enrollment period, participants will be instructed to return the device in a pre-paid envelope. The devices will stop functioning 20 days after the first use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Each participant will be assigned to one of the study's two arms. Participant's in Arm One will receive the effective device first and the placebo device second. Participants in Arm Two will receive the placebo device first and then the effective OtoBand. At the midpoint of a participant's enrollment, the first device will be returned and the second device sent. The participants and researchers will be blinded to which arm of the study a participant is assigned so they will not know if the device in use is effective or placebo.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Otoband efficacy on Tinnitus
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo device efficacy on Tinnitus
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Otoband
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
Description
The primary endpoint will be the change in THQ score of a participant while wearing an effective device versus the THQ score at enrollment/baseline.
Time Frame
Forms filled out daily over two week period by the study participant
Secondary Outcome Measure Information:
Title
Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
Description
Change in Quality of Life Measures at the conclusion of the study versus the start of enrollment as measured by the Tinnitus Handicap Questionnaire.
Time Frame
Forms filled out daily over two week period by the study participant
Title
Identification of a preferred power level for tinnitus as determined by Otoband device log.
Description
Identification of a preferred power level for tinnitus as determined by the power level that participants use for the longest cumulative use throughout the study.
Time Frame
Device use log over two week period of use by the study participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Depireux, PhD
Organizational Affiliation
Otolith Labs
Official's Role
Principal Investigator
Facility Information:
Facility Name
OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States

12. IPD Sharing Statement

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

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