Development and Evaluation of a Sleep-coaching Program

Charité University Medicine Berlin

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: sleep-coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT02896062

M/SAKE/EA002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Treatment group

Experimental group

Description:

In the treatment phase subjects receive a sleep-coaching

Treatment:

Behavioral: sleep-coaching

Waiting group control

Active Comparator group

Description:

The waiting group receives the treatment after a waiting period of up to 6 weeks

Treatment:

Behavioral: sleep-coaching