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临床试验/NCT02896062
NCT02896062已完成不适用

Development and Evaluation of a Sleep-coaching Program

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年10月1日最近更新:
适应症
干预措施

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

Experimental

In the treatment phase subjects receive a sleep-coaching

干预措施: sleep-coaching (Behavioral)

Waiting group control

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heidi Danker-Hopfe

Head of Competence Center of Sleep Medicine

Charite University, Berlin, Germany

研究点 (1)

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