Development and Evaluation of a Sleep-coaching Program

Study Overview
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Brief Summary
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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
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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.

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: sleep-coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>In the treatment phase subjects receive a sleep-coaching | Behavioral: sleep-coaching<br>* Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep<br>|
| Active Comparator: Waiting group control<br>The waiting group receives the treatment after a waiting period of up to 6 weeks | Behavioral: sleep-coaching<br>* Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective sleep quality assessed by PSQI | PSQI total score | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective sleep quality assessed by PSG | sleep efficiency | 2 months |