A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Suvorexant (Belsomra®) on Sympathetic Neural Activity and Baroreflex Function in Patients With Chronic Insomnia
试验速览
- 阶段
- 4 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Sympathetic nerve activity
研究概览
简要总结
This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.
详细描述
This study will utilize a randomized, double-blind, placebo-controlled experimental approach to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve activity and baroreflex function in male and female subjects with chronic insomnia. The study will utilize established techniques for assessing sleep (polysomnography), blood pressure (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve activity (microneurography). The study will stratify enrollment based upon both age and sex (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve activity and baroreflex function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 3 months of clinically diagnosed insomnia
- •Body mass index ≤35 kg/m2
- •Insomnia Severity Index (ISI) > 7 arbitrary units (i.e., mild-to-severe insomnia)
- •Pre-menopausal women must have regular menstrual cycles (~26-30 day cycles) and will be scheduled for microneurography 2-7 days after menstruation to consistently test during the early follicular phase (or low-hormone phase in women on contraceptives)
排除标准
- •Current or prior treatment of Suvorexant.
- •Obstructive sleep apnea defined as an apnea-hypopnea index > 30 using an FDA approved home sleep apnea screening devices as used in routine clinical practice.
- •Participants without evidence of clinically significant obstructive sleep apnea on the screening test will undergo an overnight in-laboratory polysomnography to confirm absence of sleep apnea (apnea-hypopnea index of ≥ 30 episodes per hour) and to exclude other sleep disorders (e.g. periodic limb movement arousal index of ≥ 5 episodes per hour)
- •Circadian rhythm sleep disorders
- •History of meeting DSM-V criteria of major psychiatric disorder
- •Have been clinically-diagnosed with diabetes, cardiovascular disease, or any other unstable or serious medical condition.
- •Current, or use within past month, of psychoactive (other than stable treatment with antidepressant or antianxiety), hypnotic, stimulant or analgesic medication (except occasional non-narcotic analgesics)
- •Shift work or other types of self-imposed irregular sleep schedules
- •Habitual smoking (6 or more cigarettes per week)
- •Habitual alcohol consumption (more than 2 alcoholic drinks per day)
- •Breastfeeding or pregnancy
研究组 & 干预措施
Drug (Suvorexant)
20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)
干预措施: Suvorexant (Drug)
Placebo
20 mg of Placebo daily (taken orally ~1 hour before bedtime)
干预措施: Placebo (Drug)
结局指标
主要结局
Sympathetic nerve activity
时间窗: 8 weeks
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
Baroreflex sensitivity
时间窗: 8 weeks
The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
次要结局
- Sympathetic reactivity(8 weeks)
- Home sleep quality: Wrist actigraphy(8 weeks)
- Laboratory sleep quality: Polysomnography(8 week)