Development and Evaluation of a Sleep-coaching Program

NCT ID: NCT02896062

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-11-30

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment group

In the treatment phase subjects receive a sleep-coaching

Group Type: EXPERIMENTAL

sleep-coaching

Intervention Type: BEHAVIORAL

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

Waiting group control

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

Group Type: ACTIVE_COMPARATOR

sleep-coaching

Intervention Type: BEHAVIORAL

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

Interventions

sleep-coaching

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Heidi Danker-Hopfe

Head of Competence Center of Sleep Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Charité - University Medicine Berlin

Berlin, , Germany

Countries

Germany

References

Sauter C, Kowalski JT, Stein M, Rottger S, Danker-Hopfe H. Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. J Clin Sleep Med. 2019 Mar 15;15(3):417-429. doi: 10.5664/jcsm.7666.

Reference Type: DERIVED

PMID: 30853042 (View on PubMed)

Other Identifiers

M/SAKE/EA002

Identifier Type: -

Identifier Source: org_study_id