The Effects of Zolpidem Compared With Exercise on Chronic Insomnia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change from baseline polysomographic sleep recording to first night and 6 weeks
研究概览
简要总结
Introduction: The prevalence of chronic insomnia in the general population is between 10 and 15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. Although some studies have described the effect of exercise on sleep in insomnia, there are no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect as coadjuvant therapy.
Objective: To compare the acute and chronic effects of aerobic exercise and zolpidem on sleep quality, mood and quality of life in patients with chronic insomnia.
Material and Methods: 30 patients with chronic insomnia will be randomly assigned into two groups: EXERCISE (n=15) or ZOLPIDEM (n=15). The patients of EXERCISE group will be included in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50 minutes, 3 times/week), during 6 weeks. The ZOLPIDEM group will be treated with zolpidem (10mg/night) during 6 weeks. Polysomnography, actigraphy, sleep diary and questionnaires will be used the evaluate sleep pattern. Mood and quality of life will be investigated by POMS and SF-36 questionnaires.
Hypothesis: Considering previous studies have demonstrated positive effects of aerobic exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise, performed at moderate intensity, can control the symptoms of chronic insomnia similarly to pharmacological therapy.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EXERCISE
Aerobic exercise (50% Reserve heart hate), 50 minutes, 3 times/week, during 6 weeks.
干预措施: Exercise (Behavioral)
ZOLPIDEM
10 mg/night during 6 weeks
干预措施: Zolpidem (Drug)
结局指标
主要结局
Change from baseline polysomographic sleep recording to first night and 6 weeks
时间窗: baseline, first night, week 6
Polysomnografic recording include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram. Measurements of air flow (oral and nasal), respiratory effort (thoracic and abdominal), body movement, and oxygen saturation were also taken. The measured variables included total sleep time, sleep efficiency (ratio between total sleep time and total recorded time multiplied by 100), sleep onset latency, wake after sleep onset, arousals, sleep stages (N1, N2 and N3 non-rapid eye movement \[non-REM\] sleep and REM sleep), latencies for each sleep stage. Two researchers who were blinded to the study design performed the staging and analysed the polysomnographic events using international criteria
次要结局
- Change from baseline actigraphy sleep recording to first night and 6 weeks(baseline, first night, week 6)
- Change from baseline insomnia severity to 12 weeks(baseline, week 6)
- Change from baseline sleep diary recording to first night and 6 weeks(baseline, first night, week 6)
- Change from baseline sleep quality to 6 weeks(baseline, week 6)
- Change from baseline prior sleep anxiety to first night and 6 weeks(baseline, first night, week 6)
- Change from baseline quality of life to 6 weeks(baseline, week 6)
- Change from baseline serum serotonin to first night and 6 weeks(baseline, first night, week 6)
- Change from baseline cortisol to first night and 6 weeks(baseline, first night, week 6)
- Change from baseline Effort Exercise test to 6 weeks(baseline, week 6)
- Change from baseline mood to 6 weeks(baseline, week 6)
研究者
Giselle Soares Passos
Professor
Universidade Federal de Goias