- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02896062
Development and Evaluation of a Sleep-coaching Program
May 9, 2018 updated by: Heidi Danker-Hopfe, Charite University, Berlin, Germany
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 12203
- Charité - University Medicine Berlin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment group
In the treatment phase subjects receive a sleep-coaching
|
Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep
|
ACTIVE_COMPARATOR: Waiting group control
The waiting group receives the treatment after a waiting period of up to 6 weeks
|
Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subjective sleep quality assessed by PSQI
Time Frame: 5 months
|
PSQI total score
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective sleep quality assessed by PSG
Time Frame: 2 months
|
sleep efficiency
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2014
Primary Completion (ACTUAL)
October 1, 2016
Study Completion (ACTUAL)
November 1, 2017
Study Registration Dates
First Submitted
August 31, 2016
First Submitted That Met QC Criteria
September 6, 2016
First Posted (ESTIMATE)
September 12, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 15, 2018
Last Update Submitted That Met QC Criteria
May 9, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- M/SAKE/EA002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia
-
VA Office of Research and DevelopmentVA Connecticut Healthcare System; US Department of Veterans AffairsCompleted
-
NYU Langone HealthNational Institute of Nursing Research (NINR); National Institutes of Health...CompletedInsomniaUnited States
-
Sunshine Lake Pharma Co., Ltd.Unknown
-
University of California, San FranciscoCompleted
-
Weill Medical College of Cornell UniversityWeill Cornell Medical College in QatarWithdrawn
-
Eisai Inc.CompletedInsomniaUnited States
-
SanofiCompletedInsomniaUnited States
-
National Yang Ming UniversityBened Biomedical Co., Ltd.Recruiting
-
Leiden University Medical CenterNot yet recruiting
-
Weill Medical College of Cornell UniversityMARPACCompleted
Clinical Trials on sleep-coaching
-
University of HelsinkiAcademy of FinlandUnknownSleep Disorder Circadian Rhythm, Delayed Sleep Phase TypeFinland
-
Wake Forest University Health SciencesNational Institute on Aging (NIA)RecruitingInsomnia DisorderUnited States
-
Firstbeat Technologies OyTampere University; University of Jyvaskyla; Aisti Health OyActive, not recruitingOccupational Stress | Occupational BurnoutFinland
-
Marmara UniversityCompleted
-
Mayo ClinicCompletedStress | Anxiety | Leadership | Professional Role | Goals | Well-Being | Physician's Role | Professional Burnout | Development, HumanUnited States
-
Rigshospitalet, DenmarkGilead SciencesCompleted
-
Queen Mary University of LondonBarts & The London NHS TrustCompletedCardiovascular DiseaseUnited Kingdom
-
VA Office of Research and DevelopmentAtlanta VA Medical Center; Palo Alto VA Medical CenterRecruitingCardiovascular DiseasesUnited States