Clinical trial NCT04787653: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Lead sponsor: Otolith Labs
Sponsor class: INDUSTRY
First posted: 2021-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire
timeFrame: Forms filled out daily over two week period by the study participant
Secondary outcomes:
measure: Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire
timeFrame: Forms filled out daily over two week period by the study participant
measure: Identification of a preferred power level for tinnitus as determined by Otoband device log.
timeFrame: Device use log over two week period of use by the study participant
Other outcomes:
Locations:
city: Washington
country: United States
facility: OtolithLabs https://otolithlabs.com/tinnitustelehealthstudy/
state: District of Columbia
Study officials:
affiliation: Otolith Labs
name: Didier Depireux, PhD
role: PRINCIPAL_INVESTIGATOR
References: