Treating Tinnitus Using the Neuromonics Tinnitus Treatment Program: A Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Tinnitus Reaction Questionnaire (TRQ)
研究概览
简要总结
The most current data indicate that tinnitus and hearing impairment are the Number 1 and 2 disabilities associated with service in Operations Iraqi Freedom and Enduring Freedom. Tinnitus can result from exposure to continuous noise from vehicles, generators, and other equipment, and from blast, or impulse noise from friendly-or opposing-forces weapon systems. Thus, tinnitus caused by both long-term noise exposure and acute acoustic trauma is an obstacle to be overcome in return-to-duty decisions and represents a serious liability to the retention of a healthy and fit force. Until recently, there has been no treatment that has been clinically validated as consistently effective. The development of the Neuromonics Tinnitus Treatment sought to overcome the practical limitations of previously available approaches (e.g. tinnitus maskers and biofeedback). While these studies have demonstrated the efficacy of the Neuromonics Tinnitus Treatment over alternative therapies, these trials studied target populations that may not be representative of the typical Soldier experiencing tinnitus.
One hundred and twenty (120) Soldiers or veterans with debilitating tinnitus will be recruited and divided into groups treated with two treatments, the Neuromonics Tinnitus Treatment Program which includes the use of the Neuromonics Oasis™ treatment device and a similarly-treated device using a placebo treatment. The study uses a randomized, double-blind design. The effectiveness of the treatments will be assessed using standard audiometric procedures and tinnitus subjective questionnaires.
This study will allow the Office of the Surgeon General of the Army to provide direction regarding the Neuromonics Tinnitus Treatment Program (NTTP) for alleviation of debilitating tinnitus that adversely affects Soldier deployability and operational performance. Retention of a fit force and improved quality of life for active-duty Soldiers are important issues associated with a successful approach to the treatment of tinnitus.
详细描述
BACKGROUND AND SIGNIFICANCE
Tinnitus, defined as the perception of sound when no corresponding external auditory stimulus exists, is a debilitating condition that is widespread yet difficult to successfully treat. It is estimated that between 10% and 15% of the adult population experience tinnitus to some degree. Although many people with tinnitus are not disturbed by the sensation, the condition is disabling in 0.5% to 2% of the tinnitus population or between 1.4 and 5 million people (Bauer & Brozoski, 2006). Additionally, tinnitus is among the most prevalent of service-connected disabilities for veterans receiving compensation according to the VA 2010 Annual Benefits Report, impacting over half a million veterans (US Department of Veterans Affairs, 2010).
The impact of tinnitus on a patient's quality of life can be devastating (Tyler & Baker, 1983). Many patients report that the intrusive perception of sound - such as ringing, roaring, or buzzing - interferes with their ability to relax, sleep and concentrate, especially in quiet situations. Many tinnitus patients also report reduced tolerance of loud sounds, and will tend to avoid noisy (e.g. social) situations. The disturbing effects of the condition can lead to a desperate sense of loss of control.
Until recently, there has been no treatment that has been clinically validated as consistently effective. Despite advances in understanding of the tinnitus condition, such as the Neurophysiological Model (Jastreboff & Hazell, 1993), the promise of much improved outcomes from treatment has yet to be realized in general clinical practice. Previously available treatment options continue to be limited by a lack of clinically consistent efficacy, efficiency, and/or user acceptability. Even Tinnitus Retraining Therapy (TRT), the most widely advocated practical application of the principles of the Neurophysiological Model, has been recently reported to yield only modest outcomes, and to require an extended period of time (up to 24 months) to achieve these outcomes for a high proportion of patients (J. A. Henry et al., 2005). Notably, some reports (Dineen, Doyle, Bench, & Perry, 1999; Hiller & Haerkotter, 2005; McKinney, Hazell, & Graham, 1999; Schmitt & Kroner-Herwig, 2002; Tyler, 2004) have questioned whether the acoustic stimulation used in tinnitus management programs such as TRT, predominantly consisting of broadband noise generators or hearing aids, provides any real incremental benefit over the counseling component of the program.
Furthermore, hearing aids and noise generators have been shown to provide limited clinical benefits when used in tinnitus management programs (Hiller & Haerkotter, 2005; Moffat et al., 2009), and these technologies are further limited by problems with user acceptability. Many tinnitus sufferers report that they find hearing aids intolerable to wear due to their decreased sound tolerance together with the unpredictability of amplified ambient sounds. Similarly, many people fitted with noise generators find the sound they produce unpleasant to listen to for the extended periods each day for which their use is recommended. As a result, for both hearing aids and noise generators, return-for-credit and "left-unused-in-the-drawer" rates are very high (J.A. Henry, Schecthter, Nagler, & Fausti, 2002; Hiller & Haerkotter, 2005).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If an active duty military personnel, must be between the ages of 18 to 60 years at the time of enrollment.
- •If a veteran, must be between the ages of 19 to 60 years at the time of enrollment
- •Tinnitus disturbance determined at the initial pre-enrollment assessment to be clinically significant, as denoted by a score on the TRQ of 17-70; and
- •Four frequency (0.5, 1, 2, and 4 kHz) pure tone average in one ear (0.5, 1, 2, and 4 kHz) is equal to or less than 50dB HL, as determined by audiometry performed at the initial pre-enrollment assessment; and
- •Cognitive, comprehension and manual dexterity abilities sufficient to self-administer treatment, and ability to travel to attend appointments, as necessary, as determined at the initial pre-enrollment assessment; and
- •Motivated to pursue treatment and has appropriate expectations as to treatment outcomes (including the possibility of being assigned to the placebo group), as determined at the initial pre-enrollment assessment.
- •Must have access to healthcare for follow-up care for the six month study period
排除标准
- •Refusal to give consent
- •Significant psychological disturbance [defined as any rating other than 0 on Question Number 24 the TRQ (suicidal ideology) or a score of more than 78 on the Tinnitus Handicap Inventory (THI)] that may interfere with the treatment as assessed by the treating clinician and/or referring physician;
- •Complicating medical conditions such as acute/unstable Meniere's disease as inferred by responses on the Tinnitus History Questionnaire (THQ);
- •Ongoing use of ototoxic medications (THQ);
- •Pulsatile tinnitus (THQ);
- •Continued excessive noise exposure without effective hearing protection (THQ);
- •After all elements of informed consent are completed and the TRQ has been scored, a score of less than 17 will exclude the volunteer from participation.
结局指标
主要结局
Tinnitus Reaction Questionnaire (TRQ)
时间窗: Baseline and two, four, and six months after enrollment
Change in TRQ score at 6 months compared to baseline
次要结局
- Tinnitus Reaction Questionnaire (TRQ) Awareness(Baseline and two, four, and six months after enrollment)
- Loudness Discomfort Levels (LDL) (an audiometric test)(Baseline and six months after enrollment)
- Tinnitus Reaction Questionnaire (TRQ) Midterm(Baseline and two, four, and six months after enrollment)
- Tinnitus Reaction Questionnaire (TRQ) Bothersome(Initial and two, four, and six months after enrollment)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and six months after enrollment)
- Minimum Masking Level (MML) (an audiometric test)(Baseline and six months after enrollment)
- PTSD Checklist-Military (PCL-M)(Baseline and two, four, and six months after enrollment)
研究者
William A. Ahroon, Ph.D.
Psychologist (Research)
United States Army Aeromedical Research Laboratory