Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients: A Pilot Study.Insomnia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- sleep log and actiwatch
研究概览
简要总结
To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .
详细描述
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visit 1
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to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)
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EEG
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visit 2-6
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tDCS stimulation (monday ~ friday)
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anodal / cathodal / sham
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to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
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analysis the results of sleep log and actigraphy
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visit 7 : 1 week after treatment
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to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
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analysis the results of sleep log and actigraphy
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EEG
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visit 8 : 1 month after treatment
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to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
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analysis the results of sleep log
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (older than 19 years)
- •primary insomnia
- •right handed
- •agree with participation of this study
排除标准
- •diagnosed with epilepsy or history of seizure
- •change of antipsychotic drug within 1 month
- •under suspicion of sleep apnea or periodic limb movement disorder
- •mental retardation (IQ < 70)
- •pregnant woman
研究组 & 干预措施
anodal stimulation
10 person The patients treated by anodal stimulation (2mA) for 20 minutes
干预措施: transcranial Direct Current Stimulation (Device)
cathodal stimulation
10 person The patients treated by cathodal stimulation (1-2mA) for 20 minutes
干预措施: transcranial Direct Current Stimulation (Device)
sham stimulation
10 person The patients treated by anodal stimulation (1-2mA) for 15 seconds
干预措施: transcranial Direct Current Stimulation (Device)
结局指标
主要结局
sleep log and actiwatch
时间窗: Change from baseline at 1 week
Changes of sleep quality
次要结局
- questionnaire(Change from baseline at 1 month)
- EEG spectrum analysis(Change from baseline at 1 month)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Change from baseline at 1 month)
研究者
Ki-Young Jung
professor
Seoul National University Hospital