Development and Evaluation of a Sleep-coaching Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- subjective sleep quality assessed by PSQI
研究概览
简要总结
In the present study, a 4-week sleep coaching program is developed and evaluated in members of the German armed Forces. The aim of the program is to provide an efficient tool to prevent sleep disorders, and to improve mild sleep disorders, with a special focus on insomnia.
详细描述
In the present study, a sleep-coaching program for small groups of a maximum of eight participants is developed. The program is comprised of four different sessions and is provided to member of the German armed forces. One session lasts approximately 1.5 hours and sessions are applied on a weekly basis. Each session deals with a different topic, addressing all major categories of sleep disorders (insomnia, hypersomnia, circadian rhythm disorders, sleep-related breathing disorders) and teaching ways of self-help and information on when to seek medical treatment. The program is evaluated by a cross-over study design with treatment and waiting control groups. After the treatment group has finished the course, the waiting group attends the sleep coaching session. All subjects fill in sleep logs and several questionnaires prior to (t0) and after the treatment group has finished the sleep coaching (t1), after the waiting group has finished the course (t2), and in a 3-month follow-up session (t3). Furthermore, sleep is recorded according to the AASM-standard criteria for two consecutive nights each at the time-points t0, t1, and t2. Subjective and objective sleep quality will be compared across the time-points, and between groups. In total, at least 48 participants are included in study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjectively impaired sleep quality
- •member of the German armed forces
排除标准
- •subjects with a clinically relevant psychiatric decease
- •not able to give informed consent
研究组 & 干预措施
Treatment group
In the treatment phase subjects receive a sleep-coaching
干预措施: sleep-coaching (Behavioral)
Waiting group control
The waiting group receives the treatment after a waiting period of up to 6 weeks
干预措施: sleep-coaching (Behavioral)
结局指标
主要结局
subjective sleep quality assessed by PSQI
时间窗: 5 months
PSQI total score
次要结局
- objective sleep quality assessed by PSG(2 months)
研究者
Heidi Danker-Hopfe
Head of Competence Center of Sleep Medicine
Charite University, Berlin, Germany
