Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index Score
研究概览
简要总结
The aim of this study is to determine if suvorexant can help treat the severity of insomnia and improve metabolic health in midlife women who had both insomnia and indicators of metabolic syndrome.
详细描述
The purpose of this research study is to investigate if suvorexant can help treat the severity of insomnia (a chronic sleep disorder) in midlife women and to learn whether improvement in insomnia symptoms is linked with improvement in metabolic health. This is a double-blind, randomized placebo-controlled crossover trial. Study procedures are conducted over a 14-week period (2-week screening period, 4-week treatment period [Block 1], 4-week washout, and 4-week treatment period [Block 2]). During each treatment block, participants take a daily pill - during one block, they take suvorexant and during the other block, they take a placebo (randomized to the order).
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
- 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
- •Healthy women aged 40-65 years
- •Late perimenopausal or postmenopausal
- •Meets criteria for Insomnia Disorder
- •Elevated score on the Insomnia Severity Index (ISI) consistent with clinical insomnia
- •Subjective and sustained sleep disruption during screening
- •Hot flashes present, including at night
- •Pre-diabetic per American Diabetes Association guidelines or have abnormal levels of one or more atherosclerotic cardiovascular disease risk factors per American Heart Association-defined metabolic syndrome
排除标准
- •Diagnosis of other primary sleep disorders
- •Shift worker
- •Frequent use of hypnotic medications
- •Unwillingness to refrain from taking any sleep medications during the study period
- •Current major depressive episode
- •Suicidal ideation
- •Lifetime history of bipolar disorder, psychosis, or other serious mental health problem
- •Current alcohol/substance use disorder
- •Current or prior diagnosis of diabetes mellitus
- •Use of an insulin sensitizer or a pharmacologic treatment for pre-diabetes
- •Extreme obesity
- •Current use of systemic hormonal therapies
- •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 travel across time zones
- •Excessive coffee or cigarette use
- •Unwilling to limit alcohol, nicotine, and caffeine consumption during study
研究组 & 干预措施
placebo
placebo taken at bedtime for 4 weeks
干预措施: Placebo (Drug)
suvorexant
20mg taken at bedtime for 4 weeks
干预措施: Suvorexant (Drug)
结局指标
主要结局
Insomnia Severity Index Score
时间窗: baseline to 4 weeks
The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia.
Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks
时间窗: baseline and end of each four-week intervention
The Insomnia Severity Index (ISI) is a 7-item self-rated scale to assess the severity of insomnia symptoms. The total ISI score is the sum of all questions, with a total range from 0-28 with higher values indicating worse insomnia.
次要结局
- Fasting Plasma Glucose(baseline to 4 weeks)
- Change From Baseline in Fasting Glucose Concentrations at 4 Weeks(baseline and end of each four-week intervention)
研究者
Shadab A Rahman
Study Principal Investigator
Brigham and Women's Hospital