The Effects of Eszopiclone Treatment (3mg for Two Months) to Counteract the Adverse Metabolic Consequences of Primary Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test
研究概览
简要总结
The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA.
Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia
详细描述
Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any given year, and chronically affecting 10-15% of the adult population. Reduced sleep time, independent of insomnia, has been associated with a variety of deleterious long term effects, including an increased risk of incident myocardial infarction and symptomatic diabetes. Chronic partial sleep loss or insomnia may impair glucose metabolism in the short term and are associated with the development of diabetes in the long term. Although the extent of sleep loss is more acute in the laboratory-based 'sleep debt' studies of healthy volunteers, chronic primary insomnia patients exhibit 'hyperarousal' (hypercortisolemia in the afternoon and evening, accelerated metabolism) similar to that seen with acute sleep deprivation. In addition, degradations of sleep quantity and quality in primary insomnia have been attributed to cognitive and somatic hyperarousal in the sleep setting. study examines and quantifies in adult men and women the link between primary insomnia and impaired glucose tolerance. This study examines the extent which adequate treatment of primary insomnia reverses impairments of glucose metabolism. If abnormalities of glucose metabolism are reversible, this study will demonstrate the importance of treatment of chronic primary insomnia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25-55
- •Complaint of insomnia of at least 6 months duration
- •DSM-IV diagnosis of Primary Insomnia
- •Sleep diary: mean Total Sleep Time < 6 hours and a mean total wake time (sleep latency + wake after sleep onset) of greater than 60 minutes (in previous 14 days as recorded on sleep diary)
- •A willingness to comply with study procedures
- •If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, and intrauterine device [IUD])
排除标准
- •Current diagnosis of DSM-IV Axis I disorder other than Primary Insomnia
- •Regular treatment (more than 1 time/week) with CNS active medication within 1 month of fist inpatient visit
- •Treatment with medications that interfere with glucose metabolism including anti-diabetic medications or steroidal contraceptives
- •Uncontrolled medical illness that would interfere with participation in the study
- •Body Mass Index >32 or <19.8
- •Current symptoms or diagnosis of any moderate to severe sleep disorder other than insomnia
- •No menopausal or peri-menopausal symptoms that disrupt sleep
- •Pregnant, lactating or planning to become pregnant
- •Consumption of > 2 caffeinated beverages per day (including coffee, tea and/or other caffeine-containing beverages or food) during 3 weeks prior to the start of the study
研究组 & 干预措施
eszopiclone (3mg)
active medication (eszopiclone 3mg tablet) by mouth nightly 30 min before bed
干预措施: eszopiclone (Drug)
placebo
identical placebo tablet by mouth nightly 30 min before bed
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test
时间窗: baseline and 2 months post-treatment
Difference in glucose tolerance (Kg) in response to insulin-modified intravenous glucose tolerance test. Glucose tolerance was calculated as the slope of the natural log of declining glucose values from minute 5 to minute 19 post-infusion. By convention, this negative slope is multiplied by -1, in other words, expressed as a rate of disposal.
次要结局
- Acute Insulin Response to Glucose (AIRg)(baseline and 2 months post-treatment)
- Change in Insulin Sensitivity (SI)(baseline and 2 months post-treatment)
- Change in Glucose Effectiveness (SG)(baseline and 2 months post-treatment)
- Change in HbA1c Levels(baseline and 2 months post-treatment)
- Pre-Treatment Leptin Levels(baseline)
- Post-treatment Leptin Levels(two months post-treatment)
- Pre-treatment Ghrelin Levels(baseline)
- Post-treatment Ghrelin Levels(2 months post-treatment)
- Change in Subjective Sleepiness as Measured on the Karolinska Sleepiness Scale (KSS)(baseline and 2 months post-treatment)
- Change in Mean Lapses of Attention(baseline and 2 months post-treatment)
- Change in Total Sleep Time as Reported in Sleep Diaries(baseline and 2 months post-treatment)
- Change in Total Sleep Time Measured by PSG(baseline and 2 months post-treatment)
研究者
John W. Winkelman, MD, PhD
Associate Professor of Psychiatry
Brigham and Women's Hospital