InsomniaNCT02896062
Development and Evaluation of a Sleep-coaching Program
A study testing sleep-coaching in people with Insomnia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- sleep-coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjectively impaired sleep quality
- member of the German armed forces
Who cannot join
- subjects with a clinically relevant psychiatric decease
- not able to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- sleep-coaching
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep-coachingBehavioural
Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | In the treatment phase subjects receive a sleep-coaching Receives: Behavioral: sleep-coaching |
| Waiting group control | Active comparator | The waiting group receives the treatment after a waiting period of up to 6 weeks Receives: Behavioral: sleep-coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective sleep quality assessed by PSQI
PSQI total score
Measured: 5 months
Secondary outcomes (1)
objective sleep quality assessed by PSG
sleep efficiency
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Danker-Hopfe, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896062
- Sponsor's protocol ID
- M/SAKE/EA002
- Status last verified
- May 2018
- First submitted
- 31 Aug 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30853042
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Sleep-coaching Program
- ClinicalTrials.gov ID
- NCT02896062
- Acronym / sponsor ID
- M/SAKE/EA002
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: sleep-coachingIn the treatment phase subjects receive a sleep-coaching |
| Waiting group control | Active comparator | Behavioral: sleep-coachingThe waiting group receives the treatment after a waiting period of up to 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjectively impaired sleep quality
- member of the German armed forces
Key exclusion criteria (2 listed)
- subjects with a clinically relevant psychiatric decease
- not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep-coachingSleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep | Behavioural | Treatment group, Waiting group control |
Primary outcome
subjective sleep quality assessed by PSQI
Time frame: 5 months
PSQI total score
1 secondary outcome
objective sleep quality assessed by PSG
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Derived from this study: PubMed 30853042Sauter 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep-coaching in people with Insomnia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective sleep quality assessed by PSQI (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.