Tinnitus Retraining Therapy Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 12
- 主要终点
- Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months
研究概览
简要总结
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.
详细描述
The Tinnitus Retraining Therapy Trial (TRTT), funded by the National Institute of Deafness and Other Communication Disorders, is a multi-center randomized clinical trial testing the efficacy of tinnitus retraining therapy (TRT) versus standard-of-care (SC) treatment in individuals who have self-perceived intolerable tinnitus. TRT is a non-medical intervention that uses directive counseling (DC) and low-level sound therapy (ST) achieved through sound generators (SGs) to habituate the patient's associated negative emotional reactions (annoyance) to tinnitus, its perception (awareness) and, ultimately, its impact on the participant's life. Study participants will include active and retired military personnel of the U. S. Armed Forces and their dependents who suffer from severe tinnitus. The study will be conducted at flagship Air Force, and Navy Medical Centers.
This trial will evaluate the efficacy of TRT and its components (DC and ST) versus the standard of care (SC) as administered in the military by comparing the efficacy of:
- (1) TRT (DC and ST achieved using conventional sound generators) versus SC;
- (2) TRT versus partial TRT (DC and placebo sound generators) to evaluate the separate effect of sound therapy, under the assumption that placebo noise generator will not provide any meaningful sound therapy beyond that found in SC;
- (3) partial TRT versus SC to evaluate the separate effect of DC.
Eligibility will be determined at the Baseline Eligibility Visit, which will consist of a medical and tinnitus history, physical examination, and baseline audiological/tinnitus/hyperacusis evaluation. Study participants will also complete a series of quality of life and psychological profile tests. Study Audiologists will administer the randomly assigned treatment. Follow-up visits at Clinical Centers will take place at 3, 6, 12, and 18 months and include completion of tinnitus outcome questionnaires at all visits. Psychometric testing and audiological/tinnitus/hyperacusis evaluation will take place at the 6, 12, and 18 month visits. Evaluation of audiometric pure tone and loudness discomfort level also will take place at treatment visits.
The primary outcome to be measured in the TRTT will be change in scores on the Tinnitus Questionnaire (TQ) longitudinally assessed between baseline and follow-up (i.e., at 3, 6, 12 and 18 months following treatment). Secondary outcomes include changes in the sub-scales of the TQ, change in scores from the Tinnitus Handicap Inventory (THI), Tinnitus Functional Index (TFI), Hearing Handicap Inventory (HHI), and TRT visual analogue scales, and change in the Digit Symbol Substitution Test (DSST). Psychometric secondary outcomes also include change in psychoacoustic variables related to the tinnitus sensation, including tinnitus pitch and loudness match, and loudness discomfort level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months
时间窗: Baseline to 3, 6, 12, and 18 months follow-up
The TQ is a tinnitus-specific health-related quality of life instrument with 52 statements that the respondent marks as true, partly true, or not true. The TQ is scored from 0 to 102, with higher scores indicating more of an impact of the tinnitus on quality of life. Subscales include emotional distress, intrusiveness, auditory perceptual difficulties, sleep disturbance,and somatic complaints.
次要结局
- Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months(Baseline and 3, 6, 12, and 18 months)
- Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up(Baseline to 6, 12, and 18 months follow-up)
- Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up(Baseline and 3. 6. 12. and 18 months)
- Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Handicap Inventory Functional Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)
- Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores.(Baseline to 3, 6, 12, and 18 months follow-up)