Actively Recruiting
Notched Noise Therapy for Suppression of Tinnitus
Led by VA Office of Research and Development · Updated on 2025-10-09
108
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Notched Noise Therapy for Suppression of Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veteran
- No active middle-ear disease
- At least one air conduction hearing threshold of 40 dB HL or worse in each ear between 0.25-8 kHz
- Unilateral or bilateral constant tinnitus
- Tinnitus Functional Index score of at least 25
- Mini Mental State Exam score of 24 or higher
- Tinnitus pitch match between 2-10 kHz with required precision
- Understands study requirements
- Motivated and able to participate, including English communication ability
You will not qualify if you...
- 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 greater than 15 dB at any one frequency
- Suspicion of secondary (somatic) tinnitus, Meniere's disease, or tinnitus related to temporo-mandibular disorder or whiplash
- Any mental, emotional, or health conditions that prevent full study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
Research Team
C
Candice M Quinn, PhD AuD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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