NCT07730593已完成不适用
A Pilot Study of CBT-I for the Patients With Chronic Insomnia in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change of Polysomnography (PSG) parameters - TST
研究概览
简要总结
Insomnia is one of major public health problems.This study aimed to assess benefits and problems of CBT-I for chronic insomnia based on the influence of Chinese tradition and culture.
详细描述
Participants with chronic insomnia were enrolled to a 6 weeks CBT-I program . At baseline and follow-up to week 12, all patients were assessed using polysomnography (PSG), sleep diary and subjective scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 37 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •were diagnosed as chronic insomnia based on the third edition of the International Classification of Sleep Disorders(ICSD-3) ;
- •agree to participate in this study and sign informed consent.
排除标准
- •Patient Health Questionnaire(PHQ-9)> 15 points;
- •hallucinations or taking antipsychotic medication at the time of evaluation;
- •Insomnia due to drug side effects, other illnesses or co-morbidities;
- •dementia according to 4th edition of the Diagnostic and Statistical Manual of Mental Disorders;
- •severe physical illness or severe abnormalities in heart, liver, kidney and thyroid function.
结局指标
主要结局
Change of Polysomnography (PSG) parameters - TST
时间窗: 6 weeks.
total sleep time
次要结局
- Change of Polysomnography (PSG) parameters-Stage N2(6 weeks)
- Change of Polysomnography (PSG) parameters-Stage N3(6 weeks)
- Change of Polysomnography (PSG) parameters-Arousal(6 weeks)
- Change of Polysomnography (PSG) parameters-SpO2 mean(6 weeks)
- Change of Polysomnography (PSG) parameters-SOL(6 weeks)
- Change of Polysomnography (PSG) parameters-TIB(6 weeks)
- Change of Polysomnography (PSG) parameters-SE(6 weeks)
- Change of Polysomnography (PSG) parameters-REM latency(6 weeks)
- Change of Polysomnography (PSG) parameters- Stage R(6 weeks)
- Change of Polysomnography (PSG) parameters-Stage N1(6 weeks)
- Change of Polysomnography (PSG) parameters-AHI(6 weeks)
- Change of sleep diary parameters-SOL(6 weeks)
- Change of sleep diary parameters-TST(6 weeks)
- Change of sleep diary parameters-TIB(6 weeks)
- Change of sleep diary parameters-SE(6 weeks)
- Change of sleep diary parameters-NAD(6 weeks)
- Change of sleep diary parameters-WASO(6 weeks)
- Change of lSl(12 weeks)
- Change of PSQl(12 weeks)
- Change of SAS(12 weeks)
- Change of SDS(12 weeks)
研究者
Huo Yang
Associate Chief Physician, Department of Neurology
Peking University People's Hospital
研究点 (1)
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