Clinical Trials Directory

Trials / Completed

CompletedNCT02896062

Development and Evaluation of a Sleep-coaching Program

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Charite University, Berlin, Germany · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALsleep-coachingSleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep

Timeline

Start date
2014-10-01
Primary completion
2016-10-01
Completion
2017-11-01
First posted
2016-09-12
Last updated
2018-05-15

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT02896062. Inclusion in this directory is not an endorsement.