Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| SleepScore Labs International LTD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christoph Schoebel, Prof | Ruhrlandklinik Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruhrlandklinik Essen | Essen | North Rhine-Westphalia | 45239 | Germany |
There is no plan to share IPD as data analysis will be conducted internally and raw IPD will not be shared with external researchers.
Not provided
Not provided
Not provided
Not provided
A total of 754 individuals entered prescreening and/or expressed interest ('signed up'). After eligibility screening and completion of baseline, 637 participants were randomized and started: 318 to the app and 319 to waitlist. The difference (754 to 637) reflects screening processes and incomplete baseline assessments prior to randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Allocation to Sleep Improvement App | 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) Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore: 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. |
| FG001 | Allocation to Waitlist Control Group | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants with non missing data
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Allocation to Sleep Improvement App | 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) Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants with non missing data at the specified follow up (intent to treat completer analysis). 6 week n: App 206; Control 286. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
From randomization through 12 weeks of follow up.
Non systematic assessment appropriate for a minimal risk behavioral/digital intervention. Participants were not systematically queried at each visit; however, any unanticipated problems or unexpected AEs would have been reported per protocol to the ethics committee. No deaths, serious AEs, or other AEs were reported during the randomized 12 week period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allocation to Sleep Improvement App | 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) Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore: 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanne Fischer / Sr. Manager Clinical Research | Resmed Germany Inc | +491707854257 | susanne.fischer@resmed.de |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2023 | Sep 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Oct 7, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Single-blinded Randomized Waitlist Controlled Trial
Not provided
Not provided
Not provided
|
|
SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 12 weeks |
| BG001 | Allocation to Waitlist Control Group | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Allocation to Waitlist Control Group | 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) |
|
|
|
| Primary | 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. | All randomized participants with non missing data at the specified follow up (intent to treat completer analysis). 12 week n: App 194; Control 285. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| Secondary | 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. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| Secondary | 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. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| Secondary | Changes in Mental Health Stress From Baseline to 6 Weeks | PSS 10: 10 items scored 1-5; total 10-50; higher = more stress. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| Secondary | 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. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment and completed the 12-week assessment; only those who continued frequent tracking until 12 weeks were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment and completed the 12-week assessment; only those who continued frequent tracking until 12 weeks were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment and completed the 12-week assessment; only those who continued frequent tracking until 12 weeks were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | Changes in Mental Health Stress From Baseline to 12 Weeks | PSS 10: 10 items scored 1-5; total 10-50; higher = more stress. | Secondary analyses were conducted using an adherent to treatment approach, only including participants who did sufficiently engage with the app, that is, the subgroup of app users who tracked their sleep frequently (more than three times per week) between first activation and 6-week assessment and completed the 12-week assessment; only those who continued frequent tracking until 12 weeks were included. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
|
| 0 |
| 318 |
| 0 |
| 318 |
| 0 |
| 318 |
| EG001 | Allocation to Waitlist Control Group | 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) | 0 | 319 | 0 | 319 | 0 | 319 |
Not provided
Not provided
| Baseline mental wellbeing SF-12 |
|
| 6-week follow-up mental wellbeing SF-12 |
|
| ANOVA |
Repeated measures ANOVA (Group × Time; frequent app users vs control; baseline vs week 6 |
| 0.4186 |
| Superiority |
| Baseline mental wellbeing SF-12 |
|
| 12-week follow-up mental wellbeing SF-12 |
|
| ANOVA |
Repeated measures ANOVA (Group × Time; frequent app vs control; baseline vs week 12) |
| 0.0523 |
| Superiority |