Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04661995

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States, 27705-3875

Actively Recruiting

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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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