Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus

Completed · Not applicable

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT03022084

Run by

VA National Center for Rehabilitative Auditory Research

People needed

61

Starts

2017-01-01

Expected to finish

2019-06-01

Last updated by the study team

2020-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥18 years
• Primary and persistent tinnitus (6 months or longer in duration)
• Tonal tinnitus
• 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

You may not qualify if…

• 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

Where it is running

• VA Portland Health Care System, National Center for Rehabilitative Auditory Research — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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