NCT04661995

Notched Noise Therapy for Suppression of Tinnitus

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Tinnitus is the most prevalent service-connected disability for Veterans. Many Veterans are offered sound-based (acoustic) therapy for tinnitus that is intended to alter the tinnitus perception and/or reactions to tinnitus in a clinically beneficial way. Various methods of acoustic therapy are in use and companies are promoting different products. It remains unknown; however, how certain acoustic parameters may be more effective than others. Recent research has shown the benefit of one such acoustic therapy, Notched Noise Therapy, that presents wideband sound with the tinnitus frequency region notched out, theorized to distribute lateral inhibition into the notched frequency region to suppress neural activity believed to cause the tinnitus percept. Previous studies have typically involved brief daily exposures, which are not as likely to remodel neural processes underlying tinnitus as is continuous "immersion" in background sound, which is adopted here. The proposed study will conduct a randomized controlled trial to evaluate the efficacy of notched noise therapy (NNT). The long-term goal of the research program is to develop an accessible, evidence-based treatment that reduces tinnitus loudness and to be able to assess that treatment through a validated method of behavioral and physiological clinical tools. The overall objective for this CDA-2 research plan, which is the next step toward attainment of the investigators' long-term goal, is to systematically evaluate the utility of functional, psychoacoustic, and electrophysiologic measures to reveal the overall whole-health impact in Veterans with chronic tinnitus. The trial will enroll 108 participants, who will be randomized to one of three acoustic therapy methods: amplification + notched noise, amplification + noise without notch, and amplification-only. The three groups will be asked to wear ear-level devices (combination instruments that provide both amplification and 1-10 kHz shapeable noise) as much as possible during waking hours. All participants will undergo acoustic therapy for 8 weeks and will complete outcome measures (i.e., Tinnitus Functional Index, Psychoacoustic loudness and pitch matches, AEP, and EEG measures) at baseline and at 4 and 8 weeks. They will repeat outcome assessment at 12 weeks to evaluate for maintenance of any effects while not receiving acoustic therapy for 4 weeks. (Participants requiring hearing aids for hearing loss will continue to use their aids during the 4-week no-treatment period). The investigators hypothesize that NNT suppresses tinnitus perception by distributing lateral inhibition into the notched frequency region and will therefore, reduce the perception of tinnitus loudness. At the completion of this CDA-2 program, the expected outcomes include a NNT as a therapy for tinnitus and the contributions that it may have on tinnitus perception as well as a solid training foundation for a successful VA research career. These results are expected to have an important positive impact because they will not only provide insight into the true reactionary and perceptual benefit of an intervention, but a treatment evaluation protocol will be determined, ultimately providing a foundation for the development of evidence-based acoustic therapies to treat tinnitus, a critical component and goal of Veteran tinnitus care.

Conditions

• Tinnitus
• Notched Noise Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2020-12-10
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study