Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia: A Randomized Placebo-Controlled Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Actigraphically-Derived Total Sleep Time
研究概览
简要总结
The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time in patients with effectively treated restless legs syndrome with persistent insomnia in a two-arm, double-blind, randomized placebo-controlled crossover 2.5-month trial.
详细描述
Restless Legs Syndrome (RLS) is a sensory-motor neurological disorder characterized by an irresistible urge to move the legs. Persistent difficulties with all phases of sleep are common in patients whose RLS symptoms are resolved with treatment. Multiple potential causes for treatment-refractory sleep disturbance exist, including activating effects of dopamine agonists (which are first-line RLS treatments), conditioned insomnia and poor sleep habits as a result of chronic RLS-related sleep disturbance, and comorbid medical and psychiatric illness. Suvorexant provides an important therapeutic option to treat insomnia in the context of RLS. It has demonstrated long-term efficacy, particularly in shortening the duration of nocturnal awakenings and increasing total sleep time. Similarly, it has a comparatively benign side effect profile compared to many other agents typically prescribed to treat insomnia. The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time, as well as actigraphically-derived wake after sleep onset, Insomnia Severity Index score, subjective sleep endpoints, and RLS symptom severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The participant, investigator, and clinical research coordinator will remain masked throughout the duration of the study.
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women of any ethnic origin
- •Written informed consent is obtained
- •Speaks and writes in English
- •A willingness and ability to comply with study procedures
- •Age 25-85 years
- •Diagnosis of RLS via Cambridge-Hopkins RLS questionnaire
- •International Restless Legs Syndrome Study Group scale score (IRLS) < 15
- •RLS treatment with a dopaminergic agonist or an alpha-2-delta agent
- •No changes in RLS medication in the previous month
- •DSM-5 criteria for Insomnia Disorder
- •Report a total sleep time ≤ 7 hours and wake after sleep onset (WASO) > 45 minutes on 7 or more of the 14 nightly sleep logs during both the initial 2-week screening period and the two-week screening run-in period. WASO does not decrease by more than 50% on the 2-week sleep diary obtained between the screening visit and the randomization visit
排除标准
- •Diagnosis of moderate/severe obstructive sleep apnea (AHI > 30) not using continuous positive airway pressure therapy (CPAP) (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy)
- •Shift workers
- •Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
- •Unwillingness to maintain stable RLS medication during the study unless medically indicated
- •Current use of an opiate medication
- •Unwillingness to not take stimulants (e.g. caffeine) after 4:00 pm during the study
- •Current major depressive episode, by report and as indicated by the Patient Health Questionnaire (PHQ-9)
- •Lifetime history of bipolar disorder, psychosis, or other serious psychiatric illness
- •Current alcohol/substance use disorder
- •BMI ≥ 40 kg/m^2
- •Renal or hepatic disease judged to interfere with drug metabolism and excretion
- •Pregnancy or breastfeeding
- •Malignancy within past 2 years
- •Surgery within past 3 months
- •Neurological disorder or cardiovascular disease raising safety concerns about use of suvorexant and/or judged to interfere with ability to assess efficacy of the treatment
- •Medical instability considered to interfere with study procedures
- •Concomitant medications with drug interaction or co-administration concerns
- •Contraindications or allergic responses to suvorexant
- •History of being treated with suvorexant
- •Travel across two time-zones during the week prior to enrollment
- •Greater than 6 cups of coffee per day
研究组 & 干预措施
Treatment --> Placebo
This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase.
干预措施: Suvorexant (Drug)
Treatment --> Placebo
This group will receive suvorexant during the first 4-week phase, and placebo during the second 4-week phase.
干预措施: Placebo (Other)
Placebo --> Treatment
This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase.
干预措施: Suvorexant (Drug)
Placebo --> Treatment
This group will receive placebo during the first 4-week phase, and suvorexant during the second 4-week phase.
干预措施: Placebo (Other)
结局指标
主要结局
Actigraphically-Derived Total Sleep Time
时间窗: 2 weeks
Change in mean total sleep time (between baseline and end of treatment, for each treatment period), as measured by actigraphy. Participants wear an actigraph watch, which assesses periods of activity and rest to determine the total amount of sleep during one sleep period. Total sleep time excludes sleep onset latency and nighttime awakenings.
次要结局
- Actigraphically-Derived Wake After Sleep Onset(2 weeks)
- Insomnia Severity Index(2 weeks)
研究者
John Winkelman, MD, PhD
Chief, Sleep Disorders Clinical Research Program
Massachusetts General Hospital