NCT00295386已完成4 期
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
The present study examines the short- and long-term clinical efficacy of cognitive-behavior therapy and pharmacological treatment in patients suffering from late-life primary insomnia. 46 subjects suffering from chronic primary insomnia were randomized into either cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months. Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment points.
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
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 55 years or older
- •fulfilment of the DMS-IV criteria for insomnia, including difficulties initiating sleep, maintaining sleep, and/or early morning awakenings with no ability of return to sleep
- •duration of at least 3 months
- •complaints of impaired daytime functioning.
排除标准
- •use of hypnotic medication the last 4 weeks before project start
- •use of antidepressive or antipsychotic medications
- •signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination
- •presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I)
- •presence of sleep apnea defined as (A/H index > 15) or periodic limb movements during sleep (PLM index with arousal > 15),
- •working nightshifts and unable or unwilling to discontinue this work pattern,
- •willingness or inability to stop taking sleep medication before start
- •having a serious somatic conditions preventing further participation
研究者
研究点 (2)
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