Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
研究概览
简要总结
The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
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
- 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
- •At screening visit:
- •aged 18-65
- •nonsmokers
- •for women: oral contraceptive (OC) or hormone replacement therapy (HRT) nonusers
- •To schedule the baseline PSG (Visit 2), subjects must meet the following inclusion criteria:
- •ages 18-65 inclusive;
- •PSQI-Component 2 (sleep latency) score of greater than 1;
- •non-smoker (e.g., less than 20 cigarettes in the past 5 years);
- •habitual bedtime between 8:30 pm and midnight
- •For premenopausal women:
- •regular menstrual cycles determined by Framingham Study criteria;
- •not pregnant and no history of oral contraceptive (OC) usage in last 6-months.
- •For postmenopausal women:
- •no recent (< 6 months) use of Hormone Replacement Therapy (HRT)
- •no surgical menopause
排除标准
- •positive urine drug screen
- •Potential subjects with hypersensitivity to ramelteon or any components of the formulation will be excluded from participation.
- •Given that ramelteon should not be used by individuals with severe hepatic impairment, or in patients in combination with fluvoxamine, individuals who report liver problem or use of fluvox will be excluded.
- •use of rifampin (Rifadin ©); ketoconazole (Nizora ©l); or fluconazole (Diflucan ©).
- •Ramelteon has not been studied in children or adolescents, and the effects in these populations are unknown, thus only individuals above 18 years will participate.
研究组 & 干预措施
ramelteon
Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.
干预措施: ramelteon (Drug)
placebo
15 subjects will be randomized to receive the placebo
干预措施: placebo (Drug)
结局指标
主要结局
Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)
时间窗: Baseline
The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.
Mean Latency to Persistent Sleep (LPS) Via Polysomnography
时间窗: Baseline
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.
Change in Metabolic Syndrome (MetSyn)
时间窗: Baseline, Day 30, Day 60, Day 89-90
Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)
时间窗: day 89 - 90
Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).
次要结局
- Inflammatory Biomarkers C-reactive Protein (CRP)(Baseline)
- Interleukin 6 (IL-6)(Baseline)
- Change in Total Sleep Time(Day -1-0, Day 89-90)
- Insulin Resistance (IR)(Baseline)