KCT0007292已完成未知
Multi-center, prospective, compared, randomized, single blind (subject), superiority, pivotal clinical trial to assess the efficacy and safety of Cognitive therapy software ‘Somzz’ compared to Placebo control in patients with chronic insomnia
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •All the following inclusion criteria must be met to participate in this clinical trial.
- •1. Over 19 years old.
- •2. A person who is diagnosed with chronic insomnia based on the International Classification of Sleep Disorders-3 (ICSD-3).
- •3. over 8 points on the Insomnia Severity Index (ISI).
- •4. Android phone users with OS Ver.7.0 or above.
- •5. A person who voluntarily decided to participate in this clinical trial and signed a written informed consent form.
- •6. A person who is willing to comply with the protocol.
排除标准
- •If any of the following exclusion criteria is met, one cannot participate in this clinical trial.
- •1. A person with sleep disorders other than insomnia (e.g., excessive somnolence disorder, narcolepsy, breathing related sleep disorder)
- •2. A person with insomnia caused by a physical disease that cannot be treated with Cognitive Behavioral Therapy for Insomnia (CBT-I) (e.g., asthma, gastroesophageal reflux)
- •3. A person with an underlying disorder, of which its symptoms can worsen when sleep is restricted (e.g., psychosis, bipolar disorder)
- •4. A person with severe depression (Severe according to the Hamilton Depression Rating Scale (HAMD))
- •5. A person with insomnia caused by drugs (e.g., taking drugs for chronic diseases that may increase wakefulness) or caused by certain lifestyle (e.g., overdose of caffeine drinks, excessive smoking, or excessive drinking).
- •6. A person who must carry out a schedule that is difficult to receive sleep intervention (e.g., night workers, shift workers)
- •7. A person with audiovisual or cognitive impairment, who cannot receive treatment with the Investigational Device.
- •8. A person with difficulty using general-purpose equipment such as smartphones.
- •9. A person who fails to write an electronic sleep diary seven times or more within the first 10 days.
- •10. Pregnant or lactating woman.
- •11. A person who is currently participating in other clinical trials or have participated in other clinical trials within 90 days of screening date.
- •12. In other cases, when the investigator judges that participation in the clinical trial is inappropriate because it may affect the clinical trial results or ethically.
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