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Search / Trial NCT04661995

Notched Noise Therapy for Suppression of Tinnitus

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 3, 2020

Trial Information

Current as of September 10, 2025

Enrolling by invitation

Keywords

Tinnitus Notched Noise Therapy

ClinConnect Summary

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 reg...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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)
  • Exclusion Criteria:
  • 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Durham, North Carolina, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Candice Manning Quinn, PhD AuD

Principal Investigator

Durham VA Medical Center, Durham, NC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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