Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
详细描述
Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy.
The aim of this placebo controlled study was to investigate the effect of 2 mg Melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more. Sleep was assessed by means of polysomnography (hypnographic results), all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG), actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female, aged ≥ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)
排除标准
- •According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
- •Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
- •Severe neurological, psychiatric or sleep disorders;
- •Other serious diseases;
- •Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
- •Subjects who need beta blockers as a treatment.
研究组 & 干预措施
placebo
干预措施: placebo Circadin (Drug)
Circadin
干预措施: Circadin (Drug)