NCT02896062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

August 31, 2016

Last Update Submit

May 9, 2018

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • subjective sleep quality assessed by PSQI

    PSQI total score

    5 months

Secondary Outcomes (1)

  • objective sleep quality assessed by PSG

    2 months

Study Arms (2)

Treatment group

EXPERIMENTAL

In the treatment phase subjects receive a sleep-coaching

Behavioral: sleep-coaching

Waiting group control

ACTIVE COMPARATOR

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

Behavioral: sleep-coaching

Interventions

sleep-coachingBEHAVIORAL

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

Treatment groupWaiting group control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjectively impaired sleep quality
  • member of the German armed forces

You may not qualify if:

  • subjects with a clinically relevant psychiatric decease
  • not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - University Medicine Berlin

Berlin, 12203, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30853042DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Competence Center of Sleep Medicine

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 12, 2016

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

DE(1)