Development and Evaluation of a Sleep-coaching Program

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: sleep-coaching

• Registration Number: NCT02896062
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2016-10
• Study Completion: 2017-11
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• subjectively impaired sleep quality
• member of the German armed forces

Exclusion Criteria

• subjects with a clinically relevant psychiatric decease
• not able to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment group	sleep-coaching	In the treatment phase subjects receive a sleep-coaching
Waiting group control	sleep-coaching	The waiting group receives the treatment after a waiting period of up to 6 weeks

Primary Outcome Measures

Name	Time	Method
subjective sleep quality assessed by PSQI	5 months	PSQI total score

Secondary Outcome Measures

Name	Time	Method
objective sleep quality assessed by PSG	2 months	sleep efficiency

Trial Locations

Locations (1)

Charité - University Medicine Berlin; 🇩🇪 Berlin, Germany