Health BehaviorNCT05195359
The Effects of a Personalized Sleep Improvement App From SleepScore Labs
A study testing Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore in people with Health Behavior, run by ResMed at 1 site in Germany.
Trial summary
The study is a single-blinded randomized waitlist controlled trial that aims to assess changes in objective and self-report sleep improvement through use of a dynamic and personalized sleep improvement smartphone app and advice engine in those with poor sleep (i.e., subclinical threshold insomnia) when compared to a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 637 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- iOS user
- Sub-clinical threshold insomnia symptoms (Regensburg Insomnia Scale Score 13-24)
- ≥ 18 years old.
- Naive to the SleepScore Labs App
- Able to fully understand information on data protection and provide written informed consent
Who cannot join
- Non-iOS device users due to technical restrictions of the application
- Bedtime less than 6 hours
- Any of the following medical problems:
- Untreated psychological disorder affecting sleep (e.g., depression, anxiety disorders, bipolar disorder, schizophrenia)
- Current severe medical conditions (e.g. chronic pain, cancer)
- Any of the following medications/substance use:
Show all 17Show fewer
- Prescription sleep medications or regular use of over-the-counter sleep medications
- Medication for other conditions (e.g., anxiety, ADHD) that affect sleep, e.g. antidepressants, antipsychotics
- Consumption of 3+ units of alcohol on 4 or more nights per week
- Recreational or nightly drug use
- Pregnant or nursing mothers
- Shift work
- Travel across 2 or more time zones during study period
- Sleeping more than 7 nights not at home during study period
- Users who newly received a diagnosis of a sleep disorders
- Users who start sleep or other psychoactive medication during the study period
- Use of other Sleep Tracking App's during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Personalized Sleep Improvement Smartphone Application From SleepScore Labs: A Single-blinded Randomized Waitlist Controlled Trial
The study is a single-blinded randomized waitlist controlled trial that aims to assess changes in objective and self-report sleep improvement through use of a dynamic and personalized sleep improvement smartphone app and advice engine in those with poor sleep (i.e., subclinical threshold insomnia) when compared to a waitlist control group after 6 weeks and 12 weeks.
Read the detailed description
Subclinical sleep dysfunction has a multitude of causes (e.g., environmental, cognitive, behavioral, or physiological) and symptoms (e.g., long sleep onset latency, short sleep duration, elevated wake after sleep onset and nighttime awakenings, poor sleep quality). A personalized and dynamic sleep improvement intervention tailored to an individual's lifestyle and specific needs may therefore be required to help nudge those with poor sleep towards sleep-promoting behaviors and attitudes. Digital and mobile health platforms are also highly scalable and cost-effective, thus allowing for widespread implementation across larger subclinical populations.
The purpose of the present study is to conduct a single-blinded randomized waitlist controlled trial to evaluate a novel smartphone application, Dein Schlaf. Dein Tag. powered by SleepScore, designed to both objectively measure and improve sleep. The Dein Schlaf. Dein Tag. app features a validated sonar sleep measurement tool and also provides dynamic and personalized sleep advice founded in the principles of cognitive behavioral psychology and sleep hygiene, offering a non-invasive and non-pharmacological behavioral intervention designed to improve sleep and circadian functioning in those with common sleeping difficulties. Participants will be randomly assigned to the sleep improvement app intervention or a waitlist control group. Online assessments on validated sleep and preventative health measures will take place at baseline, 6 weeks, and 12 weeks.
- Conditions
- Health Behavior
- Being tested
- Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore
- Keywords
- Sleep, Smartphone Application, Preventative Health
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScoreBehavioural
Also called SleepScore Mobile App, Dein Schlaf. Dein Tag. App
The Dein Schlaf. Dein Tag. application powered by SleepScore is a validated sleep measurement application using sonar technology that also provides evidenced-based sleep advice and sleep education content based on a user's objectively measured nightly sleep data. As participants engage with the app, the Dein Schlaf. Dein Tag. application provides personalized and dynamic sleep content and sleep and circadian rhythm improvement advice based in the principles of sleep hygiene, sleep-circadian science, and cognitive behavioral psychology. Participants will also receive personalized sleep challenges tailored to improve their sleep and circadian rhythms. Each challenge lasts for 7 tracked nights, ranging from optimizing sleep habits to limiting caffeine intake, and more. Additional sleep improvement features embedded within the app include sleep sanctuary bedroom checks, sleep sounds, smart alarms, bedtime reminders, and sleep education blogs and science content.
| Study group | Role | What they receive |
|---|---|---|
| Allocation to Sleep Improvement App | Active comparator | Participants will be instructed to engage with the Dein Schlaf. Dein Tag. smartphone app, log their behaviors in-app, and track their sleep daily for the duration of the study (12 weeks). Participants will be instructed to start the sleep tracking device via their iOS device before lying down in bed and turning off the lights to go to sleep. In the morning, participants will turn off the sleep tracking device as soon as they wake up and decide to leave the bed. At the three time points (baseline, 6 weeks, and 12 weeks), participants will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health) Receives: Behavioral: Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore |
| Allocation to Waitlist Control Group | No intervention | At the three time points (baseline, 6 weeks, and 12 weeks) participants assigned to the wait-list control group will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SF B Sleep Quality From Baseline to 6 Weeks
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Measured: Baseline and 6 weeks
Change in SF B Sleep Quality From Baseline to 12 Weeks
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Measured: Baseline and 12 weeks
Secondary outcomes (8)
Changes in Overall Sleep Problems From Baseline to 6 Weeks
PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff >5 indicates poor sleep.
Measured: Baseline and 6 weeks
Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks
SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed.
Measured: Baseline and 6 weeks
Changes in Health Measures From Baseline to 6 Weeks
SF 12 (PCS \& MCS): Norm based T scores (mean 50, SD 10); higher = better health status. We report PCS and MCS separately.
Measured: Baseline and 6 weeks
Changes in Mental Health Stress From Baseline to 6 Weeks
PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.
Measured: Baseline and 6 weeks
Changes in Overall Sleep Problems From Baseline to 12 Weeks
PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff >5 indicates poor sleep.
Measured: Baseline and 12 weeks
Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks
SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed.
Measured: Baseline and 12 weeks
Changes in Health Measures From Baseline to 12 Weeks
SF 12 (PCS \& MCS): Norm based T scores (mean 50, SD 10); higher = better health status. We report PCS and MCS separately.
Measured: Baseline and 12 weeks
Changes in Mental Health Stress From Baseline to 12 Weeks
PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start31 Jan 2023
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by ResMedThe 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
- Parallel groups
- Model description
- Single-blinded Randomized Waitlist Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SleepScore Labs International LTD
- Responsible party
- Sponsor
- Investigators
- Christoph Schoebel, Prof, Principal investigator, Ruhrlandklinik Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195359
- Sponsor's protocol ID
- 20211202DSDT
- Status last verified
- Nov 2025
- First submitted
- 3 Dec 2021
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD as data analysis will be conducted internally and raw IPD will not be shared with external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Personalized Sleep Improvement Smartphone Application From SleepScore Labs: A Single-blinded Randomized Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT05195359
- Acronym / sponsor ID
- 20211202DSDT
- Conditions
- Health Behavior
- Keywords
- Sleep, Smartphone Application, Preventative Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- SleepScore Labs International LTD
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Posted 26 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-blinded randomized waitlist controlled trial that aims to assess changes in objective and self-report sleep improvement through use of a dynamic and personalized sleep improvement smartphone app and advice engine in those with poor sleep (i.e., subclinical threshold insomnia) when compared to a waitlist control group after 6 weeks and 12 weeks.
Detailed description
Subclinical sleep dysfunction has a multitude of causes (e.g., environmental, cognitive, behavioral, or physiological) and symptoms (e.g., long sleep onset latency, short sleep duration, elevated wake after sleep onset and nighttime awakenings, poor sleep quality). A personalized and dynamic sleep improvement intervention tailored to an individual's lifestyle and specific needs may therefore be required to help nudge those with poor sleep towards sleep-promoting behaviors and attitudes. Digital and mobile health platforms are also highly scalable and cost-effective, thus allowing for widespread implementation across larger subclinical populations.
The purpose of the present study is to conduct a single-blinded randomized waitlist controlled trial to evaluate a novel smartphone application, Dein Schlaf. Dein Tag. powered by SleepScore, designed to both objectively measure and improve sleep. The Dein Schlaf. Dein Tag. app features a validated sonar sleep measurement tool and also provides dynamic and personalized sleep advice founded in the principles of cognitive behavioral psychology and sleep hygiene, offering a non-invasive and non-pharmacological behavioral intervention designed to improve sleep and circadian functioning in those with common sleeping difficulties. Participants will be randomly assigned to the sleep improvement app intervention or a waitlist control group. Online assessments on validated sleep and preventative health measures will take place at baseline, 6 weeks, and 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blinded Randomized Waitlist Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Allocation to Sleep Improvement App | Active comparator | Behavioral: Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScoreParticipants will be instructed to engage with the Dein Schlaf. Dein Tag. smartphone app, log their behaviors in-app, and track their sleep daily for the duration of the study (12 weeks). Participants will be instructed to start the sleep tracking device via their iOS device before lying down in bed and turning off the lights to go to sleep. In the morning, participants will turn off the sleep tracking device as soon as they wake up and decide to leave the bed. At the three time points (baseline, 6 weeks, and 12 weeks), participants will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health) |
| Allocation to Waitlist Control Group | No intervention | –At the three time points (baseline, 6 weeks, and 12 weeks) participants assigned to the wait-list control group will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- iOS user
- Sub-clinical threshold insomnia symptoms (Regensburg Insomnia Scale Score 13-24)
- ≥ 18 years old.
- Naive to the SleepScore Labs App
- Able to fully understand information on data protection and provide written informed consent
Key exclusion criteria (17 listed)
- Non-iOS device users due to technical restrictions of the application
- Bedtime less than 6 hours
- Any of the following medical problems:
- Any of the following medications/substance use:
- Consumption of 3+ units of alcohol on 4 or more nights per week
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 |
|---|---|---|
| Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScoreAlso: SleepScore Mobile App, Dein Schlaf. Dein Tag. AppThe Dein Schlaf. Dein Tag. application powered by SleepScore is a validated sleep measurement application using sonar technology that also provides evidenced-based sleep advice and sleep education content based on a user's objectively measured nightly sleep data. As participants engage with the app, the Dein Schlaf. Dein Tag. application provides personalized and dynamic sleep content and sleep and circadian rhythm improvement advice based in the principles of sleep hygiene, sleep-circadian science, and cognitive behavioral psychology. Participants will also receive personalized sleep challenges tailored to improve their sleep and circadian rhythms. Each challenge lasts for 7 tracked nights, ranging from optimizing sleep habits to limiting caffeine intake, and more. Additional sleep improvement features embedded within the app include sleep sanctuary bedroom checks, sleep sounds, smart alarms, bedtime reminders, and sleep education blogs and science content. | Behavioural | Allocation to Sleep Improvement App |
Primary outcome
Change in SF B Sleep Quality From Baseline to 6 Weeks
Time frame: Baseline and 6 weeks
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Change in SF B Sleep Quality From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
8 secondary outcomes
Changes in Overall Sleep Problems From Baseline to 6 Weeks
Time frame: Baseline and 6 weeks
Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks
Time frame: Baseline and 6 weeks
Changes in Health Measures From Baseline to 6 Weeks
Time frame: Baseline and 6 weeks
Changes in Mental Health Stress From Baseline to 6 Weeks
Time frame: Baseline and 6 weeks
Changes in Overall Sleep Problems From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Changes in Health Measures From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Changes in Mental Health Stress From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share IPD as data analysis will be conducted internally and raw IPD will not be shared with external researchers.
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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.
Christoph Schoebel, Prof principal investigator
Ruhrlandklinik Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore in people with Health Behavior, run by ResMed 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 5 inclusion and 17 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 26 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in SF B Sleep Quality From Baseline to 6 Weeks (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.