Tinnitus Retraining Therapy Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Subjective Tinnitus

In brief

The primary purpose of the Tinnitus Retraining Therapy Trial (TRTT) is to assess the efficacy of tinnitus retraining therapy (TRT) as a treatment for severe debilitating tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and sound therapy (ST)to habituate the patient's associated negative emotional reactions to tinnitus, its perception, and ultimately, its impact on the patient's life.

Key facts

Study ID

NCT01177137

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

151

Starts

2011-07-01

Expected to finish

2017-02-01

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or above
• Subjective severe tinnitus, defined as a score on the Tinnitus Questionnaire (TQ) greater than or equal to 40
• Eligible for care at a Department of Defense Clinical Center
• Speaks English well enough to complete a series of questionnaires and benefit from counseling

You may not qualify if…

• Involvement in pending tinnitus-related financial claims or litigation except that associated with usual Veterans' Administration retirement claims
• Tinnitus of less than 12 months duration
• Treatment for tinnitus within previous 12 months
• Routine unavoidable exposure to hazardous noise
• Use of a cancer chemotherapeutic drug within previous 12 months
• Treatment for head or neck injury within previous 24 months
• Treatment for an emotional, psychological, or psychiatric condition within previous 12 months resulting in inability to participate in the trial or complete all followup visits, as assessed by best clinical judgment
• Requirement for use of an ototoxic drug
• Hearing impairment, defined by audiometric thresholds > 30 dB HL at and below 2,000 Hz and > 40 dB HL at 4,000 and 8,000 Hz
• Required use of hearing aids
• Fluctuating hearing loss at a level that would interfere with the reliability of study results
• One or more prominent spontaneous otoacoustic emissions, defined as the presence of a spontaneous otoacoustic emission spike that is 3 or more times larger than the measured variation in amplitude across the remaining frequency range and/or if the emission corresponds in pitch to the tinnitus pitch
• Pulsatile somatosounds suggesting presence of abnormal vasculature or high blood pressure contributing to the tinnitus
• Feigning tinnitus or hearing loss
• Evidence by audiological testing of a treatable etiology of the tinnitus, such as conductive hearing impairment as shown by pure-tone thresholds, abnormal acoustic immittance, abnormal stapedial reflex test, or abnormal auditory brainstem response
• Predisposing disease with tinnitus symptoms amenable to medical or surgical intervention, including but not limited to; chronic otitis media, otosclerosis, vestibular disorder or dizziness, Eustachian tube, middle ear, or inner ear disease, Lyme disease or ear autoimmune disease, malocclusion or temporomandibular joint disease, uncontrolled allergies, aberrant ear, head, or neck blood vasculature or glomus tumor, neurological condition such as multiple sclerosis or ear-related demyelinating disease, perilymphatic fistula, or facial weakness or paralysis
• Meniere's disease
• Uncontrolled diabetes, defined as blood glucose consistently ≥ 200 mg/dl or an HBA1c above 8%
• Evidence from any laboratory study that suggests an etiology for the tinnitus that is treatable, including, but not limited to, abnormal thyroid stimulating hormone (TSH) or thyroid hormone (T3 or T4) levels, positive fluorescent treponemal antibody (FTA) test, or positive Lyme titer
• Evidence of a tumor contributing to the tinnitus, including an acoustic neuroma (or vestibular schwannoma), cerebellopontine angle tumor, skull base tumor, or any other type of tumor that the examining physician believes is responsible for the tinnitus
• Diagnosis of traumatic head or brain injury requiring treatment
• Diagnosis of an emotional, psychological, or psychiatric condition requiring treatment and resulting in inability to participate in the trial or complete all followup visits, as assessed by best clinical judgment
• Inability or unwillingness of patient to comply with study requirements
• Unwillingness of Clinical Center Director to randomize the patient to treatment due to the presence of any condition, physical, mental or social, which is likely to affect the patient returning for follow-up visits on schedule or which is likely to impair his or her performance on the functional tests
• Inability or unwillingness of patient to provide informed consent

Where it is running

• Naval Hospital Camp Pendleton — Camp Pendleton, California, United States
• Naval Medical Center — San Diego, California, United States
• David Grant Medical Center — Travis Air Force Base, California, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Wilford Hall Medical Center — Lackland Air Force Base, Texas, United States
• Portsmouth Naval Medical Center — Portsmouth, Virginia, United States

Full record on ClinicalTrials.gov

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