NCT04787653

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Otolith Labs · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-05
• Primary completion: 2024-01-31
• Completion: 2024-02-28
• First posted: 2021-03-08
• Last updated: 2022-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study