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Development and Evaluation of a Sleep-coaching Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02896062
Enrollment
48
Registered
2016-09-12
Start date
2014-10-31
Completion date
2017-11-30
Last updated
2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

BEHAVIORALsleep-coaching

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

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
subjective sleep quality assessed by PSQI5 monthsPSQI total score

Secondary

MeasureTime frameDescription
objective sleep quality assessed by PSG2 monthssleep efficiency

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026