Development and Evaluation of a Sleep-coaching Program

Insomnia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896062
• Other study ID #: M/SAKE/EA002
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: November 2017

Study information

• Verified date: May 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• sleep-coaching
Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective sleep quality assessed by PSQI	PSQI total score	5 months
Secondary	objective sleep quality assessed by PSG	sleep efficiency	2 months