A Double-blind, Randomized, Placebo-controlled Study to Determine the Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia in Midlife Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Within-person Change in ISI Score
研究概览
简要总结
The aim of this study is to determine the effect of suvorexant on insomnia symptoms in peri- and postmenopausal women who are experiencing sleep difficulties related to nighttime hot flashes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Peri- or postmenopausal women
- •DSM-5 criteria for Insomnia disorder, with onset of symptoms attributed to hot flashes
- •Some awakenings co-occur with a hot flash
- •Score on the Insomnia Severity Index (ISI) measure ≥15
- •Hot flashes present, including at night
排除标准
- •Diagnosis of other primary sleep disorders
- •Shift workers
- •Current or expected use of hypnotic medications
- •Current major depressive episode
- •Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
- •Current alcohol/substance use disorder
- •Renal or hepatic disease
- •Pregnancy or breastfeeding
- •Recent malignancy
- •Recent surgery
- •Neurological disorder or cardiovascular disease raising safety concerns
- •Medical instability considered to interfere with study procedures
- •Concomitant medications with drug interaction or co-administration concerns
- •Contraindications or allergic responses to suvorexant
- •Recent or planned travel across time zones
- •Excessive coffee or cigarette use
研究组 & 干预措施
suvorexant
suvorexant 10-20 mg taken at bedtime for four weeks
干预措施: suvorexant (Drug)
placebo
placebo taken at bedtime for four weeks
干预措施: placebo (Drug)
结局指标
主要结局
Within-person Change in ISI Score
时间窗: baseline and 4 weeks
The Insomnia Severity Index (ISI) is a scale comprising seven questions scored 0-3. The total ISI score is the sum of all questions, with a total range from 0-21 with higher values indicating worse insomnia. Within-person change in ISI score from baseline to 4 weeks was calculated.
次要结局
未报告次要终点
研究者
Hadine Joffe, MD MSc
Executive Director, Connors Center for Women's Health and Gender Biology
Brigham and Women's Hospital