The purpose of this study is to determine if a novel sound-based therapy in comparison to
standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects
for people with bothersome tinnitus.
Other: Cognitive Behavioral Therapy
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Locations near you
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Full eligibility criteria for NCT03022084
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Age ≥18 years
Primary and persistent tinnitus (6 months or longer in duration)
Dominant tinnitus frequency measured between 0.2 and 10 kHz
Tinnitus Questionnaire score
No current participation in other tinnitus therapy program
Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial
Able to pass the Tone Audibility Assessment with factor of 1.1
Secondary/somatic tinnitus due to a suspected underlying disease
Atonal, pulsatile, intermittent, or occasional tinnitus
Any hearing threshold >70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1
Any health or other problems that may prevent the person from completing the study procedures as determined by investigator
Participant reports current suicidal ideation and/or homicidal ideation
Use of medication which may trigger tinnitus [e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs
≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin]
Conductive hearing loss
Visible congenital or traumatic deformity of the ear
History of active drainage from the ear within the past 90 days
History of sudden or rapidly progressive hearing loss within the past 90 days
Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures
Previous use of Desyncra for Tinnitus Therapy System
All locations for NCT03022084
United States (1)
VA Portland Health Care System, National Center for Rehabilitative Auditory Research
Portland, Oregon, United States, 97239
View full eligibility
Tris trial is registered with FDA with number: NCT03022084. The sponsor of the trial is VA National Center for Rehabilitative Auditory Research and it is looking for 61 volunteers for the current phase.
Official trial title: Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus
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