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

NCT04787653 | Unknown DMC FDA Device

• 1 other identifier: OLith10801
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• 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.

  Forms filled out daily over two week period by the study participant

Secondary Outcomes (2)

• Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire

  Forms filled out daily over two week period by the study participant

• Identification of a preferred power level for tinnitus as determined by Otoband device log.

  Device use log over two week period of use by the study participant

Study Arms (2)

Otoband efficacy on Tinnitus

ACTIVE COMPARATOR

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.

Device: Otoband

Placebo device efficacy on Tinnitus

PLACEBO COMPARATOR

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.

Device: Placebo

Interventions

Otoband DEVICE

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.

Otoband efficacy on Tinnitus

Placebo DEVICE

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.

Placebo device efficacy on Tinnitus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otolith Labs: lead

Study Sites (1)

OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/

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

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Didier Depireux, PhD

  Otolith Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 8, 2021
• Study Start: March 5, 2021
• Primary Completion: January 31, 2024
• Study Completion: February 28, 2024
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

US (1)