KCT0008707终止Unknown
A prospective randomized clinical trial to evaluate the safety and efficacy of SMD sleepdoc digital therapy devices used to quantitatively improve insomnia symptoms in patients diagnosed with non-organic insomnia
SMDsolutions0 个研究点目标入组 54 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 终止
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Adults over 19 years of age
- •2) Diagnosis of nonorganic insomnia disorder (F51.0) of ICD-10 or sleep initiation and maintenance disorder by satisfying the criteria for diagnosis of nonorganic insomnia disorder of DSM-5 or the third edition of International Classification of Sleep Disorders , A person diagnosed with insomnia disorder (G47.0)
- •3) A person who satisfies 8 points or more on the Insomnia Disorder Severity Scale (ISI)
- •4) Those who have no difficulty in reading and writing Korean
- •5) Those who have no difficulty in using mobile applications using general-purpose equipment (smartphone or tablet PC, etc.)
- •6) A person who voluntarily decides to participate and agrees face-to-face to abide by the precautions after receiving and understanding sufficient explanations about this clinical trial
- •7) Android smartphone users
排除标准
- •1) DSM-5 other sleep arousal disorders other than insomnia (hypersomnia, narcolepsy, breathing-related
- •Sleep disorder, circadian rhythm sleep arousal disorder, parasomnia) diagnosed
- •2) Those with insomnia due to physical illness or medications
- •3) A person with symptoms corresponding to a diagnosis of schizophrenia spectrum disorder, a diagnosis of bipolar disorder, or a person with symptoms corresponding to a major depressive episode at the time of basic evaluation
- •4) Has attempted suicide within the last 3 months, and committed suicide by a psychiatrist
- •Those who are judged to be in the high-risk group
- •5) Has there been any other cognitive-behavioral therapy that has been newly started or ongoing within the last 3 months
- •In this case, all other types of cognitive behavioral therapy, including insomnia, are included.
- •6) shift workers
- •7) Those with hearing impairment or cognitive impairment (e.g. dementia, etc.)
- •8) Those who have difficulty hearing, writing, and speaking Korean
- •9) Those who are contraindicated for sleep restriction treatment (pregnant women, students taking an exam, epilepsy, truck drivers or
- •Long-distance bus drivers, heavy machinery drivers, etc., whose daytime sleepiness can have fatal consequences)
- •10) Those who have difficulty using general-purpose equipment (smartphone or tablet PC, etc.)
- •11) Those who are judged by the investigator to be unsuitable for participation in clinical trials due to other reasons
- •12) Those who have changed the type and dose of drugs that directly affect sleep within the last 1 month
- •13) pregnant women
研究者
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