Tinnitus Retraining Therapy Trial
Condition: Subjective Tinnitus
MeSH terms: Tinnitus
Intervention: Conventional sound generator (SG); Placebo sound generator (placebo SG); Standard of Care (SC); Directive Counseling (DC); Directive Counseling (DC)
Intervention description: Conventional SGs: Tranquil model sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate low-level noise, which is set at or just below the patient's mixing point (i.e., the noise level that just blends with the study participant's tinnitus); Tranquil model placebo sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate a sound different from the active devices.; The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.; Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.; Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tinnitus; tinnitus retraining therapy; standard of care; directive counseling; sound therapy; tinnitus questionnaire; tinnitus handicap inventory

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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