Acupuncture for the Treatment of Insomnia - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Sleep efficiency on polysomnography
研究概览
简要总结
Insomnia is a common and disabling condition associated with psychiatric and medical comorbidities and often persists despite currently available treatments. Acupuncture has been reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT will investigate the impact of a standardized acupuncture protocol on insomnia, daytime symptoms, and hyperarousal.
详细描述
Insomnia is a common problem that is disabling and that frequently persists despite available medical and behavioral approaches. It is associated significant psychiatric and medical comorbidities and high medical and societal costs. Benzodiazepine receptor agonists (BzRA's) and cognitive behavioral therapies are common treatments, but despite these, insomnia remains a pervasive problem. Complementary and alternative medicine (CAM) treatments are being used widely for the treatment of insomnia, but many of these modalities have sparse research support. There are numerous reports in the Traditional Chinese Medicine (TCM)literature of dramatic benefits of acupuncture for the treatment of insomnia, but carefully designed studies are limited. Insomnia has been associated with hyperarousal and acupuncture has documented effects on autonomics with a shift towards parasympathetic predominance. In consultation with experts in acupuncture and TCM, we developed a protocol for the treatment of insomnia and have used it clinically with good success.
We will be conducting a 3-year exploratory pilot randomized-controlled blinded trial (RCT) of this protocol on 56 adults with insomnia disorder, utilizing a control condition involving placement of placebo needles. We seek to determine the effect size of this acupuncture intervention in comparison to the control condition in preparation for a more definitive study, with the future primary aim to determine if acupuncture is effective and well tolerated in the treatment of insomnia. Measures will include self-report and objective measures of sleep quality and duration including polysomnography (PSG). Secondary-exploratory aims will be to determine the impact of this acupuncture protocol on daytime symptoms of insomnia such as fatigue, anxiety, and depression as well as to explore the impact of acupuncture on self-report and objective measures of hyperarousal.
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, Investigator, Outcomes Assessor)
盲法说明
Subjects were unaware of whether they were receiving verum or sham treatment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-60;
- •Ability to speak, read, and write English;
- •Insomnia disorder, as defined by RDC, of 3 months or greater duration.
排除标准
- •Presence of serious psychiatric Axis I DSM-IV disorders such as bipolar or psychotic disorders-as individuals with conditions may respond differently than insomnia disorder to the acupuncture intervention, potentially confounding the results;
- •Active suicidal ideation or active psychosis, as this may present a concern regarding safety for a subject's participation in this study;
- •Presence of depressive or anxiety disorders of moderate or greater severity based on either HAM-D scores or HAM-A scores of 14 or greater;
- •Presence of unstable medical conditions commonly associated with significant sleep disturbance, e.g. uncompensated congestive heart failure, as this would not be expected to respond to the acupuncture intervention;
- •Presence of other sleep disorder, such as periodic limb movement disorder or sleep apnea, as these conditions would require other medical treatment-this will be based on known history of sleep disorder or findings on screening PSG of apnea-hypopnea index of > 10 or periodic limb movement index of >10;
- •Alcohol use > 14 beverages/week, as this may impact on response to the intervention and assessment measures;
- •Ongoing use of any recreational drugs;
- •Ongoing use of benzodiazepines, prescription hypnotic medication, over-the-counter hypnotic medication, or nutritional supplements with purported hypnotic effects;
- •Ongoing use of other psychotropic medication, such as psychostimulants, or antipsychotics;
- •Caffeine use > the equivalent of 5 cups of coffee/day;
- •Pregnancy, as the safe use of acupuncture in pregnancy has not been established;
- •Active malignancy, autoimmune condition, or treatment with immunosuppressive drugs;
- •Presence of coagulopathy or use of anticoagulant medication;
- •Active involvement in any psychotherapy or other treatment specifically directed towards insomnia;
- •Prior experience with acupuncture treatment in the last 6 months or prior participation in an acupuncture research study.
研究组 & 干预措施
Sham acupuncture
Sham acupuncture at non-active acupuncture points, using the Park Sham Device
干预措施: Acupuncture (Other)
Verum Acupuncture
Acupuncture following a specific TCM-based protocol
干预措施: Acupuncture (Other)
结局指标
主要结局
Sleep efficiency on polysomnography
时间窗: Baseline and post-intervention
PSG is the "gold standard" objective measure of sleep, which complements in-home diary measures and actigraphy. PSG provides objective physiologic data under controlled, albeit artificial (laboratory) conditions and is considered an essential component of demonstrating the efficacy of both drug and non-pharmacologic treatments of insomnia.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, EOI, & 3 months post-tx
A 19-item questionnaire developed by Buysse et. al. that rates the subject's habitual sleep over the past month(109). The 19 questions are combined into seven clinically-derived component scores, each weighted equally from 0-3. The seven component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
Insomnia Severity Index (ISI)
时间窗: Baseline, EOI, & 3 months post-tx
A 7-item survey which rates satisfaction with different aspects of sleep over the prior two weeks on a 0-4 Likert scale for a total score of 28, with a higher score reflecting greater severity of insomnia(126). Criteria are specified to categorize response into one of four severity groups, with a change of one level considered significant.
次要结局
- Epworth Sleepiness Scale (ESS)(Baseline, EOI, & 3 months post-tx)
- Multidimensional Fatigue Inventory (MFI)(Baseline, EOI, & 3 months post-tx)
- Inventory for Depressive Symptomatology-Self-Rated (IDS-SR)(Baseline, EOI, & 3 months post-tx)
- State version of the Spielberger State-Trait Anxiety Inventory (STAI-s)(Baseline, EOI, & 3 months post-tx)
- The Pre-Sleep Arousal Scale (PSAS)(Baseline, EOI, & 3 months post-tx)
- Pittsburgh Sleep Diary (PghSD) and actigraphy recording(Baseline, EOI, & 3 months post-tx)
- Autonomic arousal as measured by HRV & Q-EEG during sleep recording(Baseline & EOI)
研究者
Ronald M. Glick
Assistant Professor
University of Pittsburgh