JPRN-jRCT2032210071已完成3 期
Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yukumi in patients with insomnia disorders (verification study)
eno Taro0 个研究点目标入组 156 人开始时间: 2021年5月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Insomnia disorder (ICSD-3).
- •2. Patients who can understand Japanese.
- •3. Patient who has smartphone.
排除标准
- •1. Patients with Athens Insomnia Scale (AIS) at the getting consent or beginning of the trial less than 9 points.
- •2. Patients who have experienced drug treatment for insomnia within the past 14 days.
- •3. Patients without a sleeping diary since 7 days from the start of the trial, or Patients who do not need further improvement.
- •4. Patients suspected or suffering from the following diseases.
- •Mental illness
- •Sleep apnea syndrome
- •Sleep-related movement disorder
- •Central hypersomnia
- •Accompanying sleep
- •Circadian rhythm disturbance
- •drug addiction
- •immune disease
- •5. Pregnant women, lactating women
- •6. Patients who are engaged in jobs requiring driving such as automobiles or motorbikes or jobs involving danger or scheduled to participate during the trial participation period.
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