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RECRUITING
NCT04661995
NA

Notched Noise Therapy for Suppression of Tinnitus

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

Tinnitus ("ringing in the ears") has long been a problem for Veterans. The problem continues to escalate due to high levels of noise in the military, and because tinnitus often is associated with traumatic brain injury and post-traumatic stress disorder. In spite of limited research support, sound-based (acoustic) therapies are most often used for tinnitus intervention, and increasing numbers of commercial devices are becoming available that offer various acoustic-stimulus protocols. The proposed study will provide evidence from a randomized controlled trial comparing effects of acoustic-stimulus methods that are purported to suppress tinnitus and/or reduce its functional effects. The study will focus on methods with the strongest scientific rationale, i.e., noise that is notched around the predominant tinnitus-frequency region. Special ear-level devices will deliver these acoustic-therapy protocols that are purported to modify tinnitus-related neural activity. The study will follow a study recently completed by the applicant that provides preliminary evidence supporting this method.

Official title: Notched Noise Therapy for Suppression of Tinnitus: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2023-03-01

Completion Date

2026-05-31

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Hearing Aid and Notched Noise Therapy

Notched Noise Therapy involves presenting wide-band sound with the tinnitus frequency region notched out, referred to as notched noise, or notch therapy. This procedure may distribute lateral inhibition into the notched frequency region, suppressing tinnitus neural activity believed to be occurring there. This type of therapy is provided through a sound file that is streamed through hearing aids.

COMBINATION_PRODUCT

Hearing Aid and Broadband Noise

Broadband Noise, or "white noise," is a common tinnitus sound therapy treatment option. It is also commonly used as a "masker" noise for individuals with tinnitus that like to enrich their environment with sound.

DEVICE

Hearing Aid

A-O groups will use ear-level, self-contained devices (hearing aids) that (1) are capable of streaming shapeable broadband noise between 1-10 kHz; (2) allow for normal conversation; and (3) are comfortable, easy to use, and discrete. These criteria describe a behind-the-ear hearing aid with the capability of streaming custom sounds. Hearing aids are used to provide amplification to those with hearing loss and are fit by licensed audiologists. Sometimes, hearing aids can provide benefit to those with bothersome tinnitus.

Locations (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States