JPRN-jRCT2032230353招募中2 期
A two-arm, randomized, open-label, multicenter exploratory study to evaluate the efficacy and safety of a cognitive behavioral therapy application (IIIP MED: Sleepy Med) for patients with insomnia, using zolpidem tartrate as a control.
Shimizu Eiji0 个研究点目标入组 30 人开始时间: 2023年9月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Screening step 1
- •(1) Age 18 years and older
- •(2) Meets DSM-5 diagnostic criteria for insomnia disorder
- •(3) ISI score >= 11
- •(4) Has internet access at home and can operate a smartphone or a tablet
- •Screening step 2
- •(1) Patients with subjective sleep onset latency (sSOL) of >= 30 minutes after keeping a sleep diary for at least 3 days
- •(2) Patients who have insomnia symptoms (ISI score >= 11) at 4 weeks after sleep hygiene education by a physician
- •(3) Patients who have not received pharmacotherapy or cognitive behavioral therapy for insomnia for 4 weeks at screening step 2
排除标准
- •Screening step 1
- •(1) Patients with hypersomnolence disorder, narcolepsy, breathing-related sleep disorders, or parasomnias
- •(2) Patients with symptoms suspected of hypersomnolence disorder, narcolepsy, breathing-related sleep disorders, or parasomnias according to the investigator's or subinvestigator's clinical opinion
- •(3) Patients with moderate or higher anxiety symptoms (GAD-7 score >= 10)
- •(4) Patients with moderate or higher depressive symptoms (PHQ-9 >= 10)
- •(5) Patients with suicidal ideations (the ninth item of PHQ-9, suicidal ideation score >= 2 )
- •(6) Patients who habitually go to bed later than 2 am or wake up later than 10 am due to night shift
- •(7) Patients who are pregnant, breastfeeding (including discontinued breastfeeding), or planning a pregnancy during the study
- •(8) Patients who have been diagnosed by a medical institution as having alcohol or drug dependence within the past year (not including habitual smokers)
- •(9) Patients with any condition that may affect the safety of the subject or the conduct of this study (e.g., may affect sleep)
- •(10) Patients who are engaged in dangerous mechanical operations such as driving a car
- •(11) Patients who are currently participating in another clinical trial
- •(12) Patients who have received cognitive behavioral therapy for insomnia in the past
- •(13)Other patients who are judged by the investigator or sub investigator to be inappropriate to participate in this clinical trial.
- •Screening step 2
- •(1) Patients with the following diseases that the investigator or subinvestigator determines may affect the safety of the subject or the conduct of this clinical trial
- •(2) Other patients who are judged by the investigator or sub investigator to be inappropriate to participate in this clinical trial.
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