Status:
RECRUITING
Notched Noise Therapy for Suppression of Tinnitus
Lead Sponsor:
VA Office of Research and Development
Conditions:
Tinnitus
Notched Noise Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 trau...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04661995
Start Date
March 1 2023
End Date
May 31 2026
Last Update
October 9 2025
Active Locations (1)
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1
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875