Notched Noise Therapy for Suppression of Tinnitus

Completed · Not applicable

Conditions studied: Tinnitus, Notched Noise Therapy

In brief

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.

Key facts

Study ID

NCT04661995

Run by

VA Office of Research and Development

People needed

108

Starts

2023-03-01

Expected to finish

2026-05-31

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidates must meet the following inclusion criteria to qualify:
• Veteran
• no active middle-ear disease
• at least one air conduction hearing threshold of 40 dB HL or worse in each ear between .25-8 kHz as measured at the first study visit
• unilateral or bilateral constant tinnitus
• index score on the Tinnitus Functional Index (TFI) of at least 25 (out of a maximum score of 100)
• a score of 24 or higher on the Mini Mental State Exam (MMSE)
• a tinnitus pitch match between 2-10 kHz (and achieve desired level of precision as described below in 3.3 Study Procedures, Tinnitus Psychoacoustic Assessment)
• demonstrates understanding of the requirements of the study
• motivated and capable of participating (including ability to communicate in English)

You may not qualify if…

• The following exclusion criteria will be used:
• two or more hearing thresholds exceeding 70 dB HL
• significant conductive hearing loss-defined as an air-bone gap of 15 dB at more than two frequencies in one ear, or an air-bone gap greater than 15 dB at any one frequency
• suspicion of secondary (somatic) tinnitus, Meniere's disease, or tinnitus potentially related to temporo-mandibular disorder or whiplash (any of which can be ruled out with an examination by an appropriate physician)
• any mental, emotional, or health conditions that would preclude full study participation

Where it is running

• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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