Trial Outcomes & Findings for The Effects of a Personalized Sleep Improvement App From SleepScore Labs (NCT NCT05195359)
NCT ID: NCT05195359
Last Updated: 2025-11-26
Results Overview
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
637 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2025-11-26
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
318
|
319
|
|
Overall Study
COMPLETED
|
194
|
285
|
|
Overall Study
NOT COMPLETED
|
124
|
34
|
Reasons for withdrawal
| Measure |
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.
|
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
124
|
34
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Allocation to Sleep Improvement App
n=318 Participants
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.
|
Allocation to Waitlist Control Group
n=319 Participants
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)
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12 • n=318 Participants
|
42 years
STANDARD_DEVIATION 13 • n=319 Participants
|
42 years
STANDARD_DEVIATION 13 • n=637 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=318 Participants
|
253 Participants
n=319 Participants
|
495 Participants
n=637 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=318 Participants
|
66 Participants
n=319 Participants
|
142 Participants
n=637 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
318 participants
n=318 Participants
|
319 participants
n=319 Participants
|
637 participants
n=637 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: All randomized participants with non missing data at the specified follow up (intent to treat completer analysis). 6 week n: App 206; Control 286.
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=206 Participants
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.
|
Allocation to Waitlist Control Group
n=286 Participants
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)
|
|---|---|---|
|
Change in SF B Sleep Quality From Baseline to 6 Weeks
6-week follow-up
|
2.98 score on a scale
Standard Deviation 0.51
|
2.81 score on a scale
Standard Deviation 0.60
|
|
Change in SF B Sleep Quality From Baseline to 6 Weeks
Baseline
|
2.73 score on a scale
Standard Deviation 0.51
|
2.73 score on a scale
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All randomized participants with non missing data at the specified follow up (intent to treat completer analysis). 12 week n: App 194; Control 285.
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=194 Participants
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.
|
Allocation to Waitlist Control Group
n=285 Participants
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)
|
|---|---|---|
|
Change in SF B Sleep Quality From Baseline to 12 Weeks
Baseline
|
2.75 score on a scale
Standard Deviation 0.50
|
2.73 score on a scale
Standard Deviation 0.56
|
|
Change in SF B Sleep Quality From Baseline to 12 Weeks
12-week follow-up
|
3.05 score on a scale
Standard Deviation 0.51
|
2.86 score on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff \>5 indicates poor sleep.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=121 Participants
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.
|
Allocation to Waitlist Control Group
n=286 Participants
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)
|
|---|---|---|
|
Changes in Overall Sleep Problems From Baseline to 6 Weeks
Baseline
|
8.54 score on a scale
Standard Deviation 3.02
|
8.47 score on a scale
Standard Deviation 3.37
|
|
Changes in Overall Sleep Problems From Baseline to 6 Weeks
6-week follow-up
|
7.14 score on a scale
Standard Deviation 2.65
|
8.24 score on a scale
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=121 Participants
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.
|
Allocation to Waitlist Control Group
n=286 Participants
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)
|
|---|---|---|
|
Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks
Baseline
|
2.68 score on a scale
Standard Deviation 0.63
|
2.68 score on a scale
Standard Deviation 0.77
|
|
Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks
6-week follow-up
|
2.86 score on a scale
Standard Deviation 0.70
|
2.75 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
SF 12 (PCS \& MCS): Norm based T scores (mean 50, SD 10); higher = better health status. We report PCS and MCS separately.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=121 Participants
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.
|
Allocation to Waitlist Control Group
n=286 Participants
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)
|
|---|---|---|
|
Changes in Health Measures From Baseline to 6 Weeks
6-week follow-up physical wellbeing SF-12
|
53.13 score on a scale
Standard Deviation 8.09
|
50.45 score on a scale
Standard Deviation 9.11
|
|
Changes in Health Measures From Baseline to 6 Weeks
Baseline mental wellbeing SF-12
|
37.31 score on a scale
Standard Deviation 6.15
|
38.16 score on a scale
Standard Deviation 6.68
|
|
Changes in Health Measures From Baseline to 6 Weeks
6-week follow-up mental wellbeing SF-12
|
38.56 score on a scale
Standard Deviation 7.16
|
38.77 score on a scale
Standard Deviation 6.69
|
|
Changes in Health Measures From Baseline to 6 Weeks
Baseline physical wellbeing SF-12
|
52.70 score on a scale
Standard Deviation 6.62
|
51.01 score on a scale
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=121 Participants
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.
|
Allocation to Waitlist Control Group
n=286 Participants
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)
|
|---|---|---|
|
Changes in Mental Health Stress From Baseline to 6 Weeks
Baseline
|
28.62 score on a scale
Standard Deviation 6.34
|
28.87 score on a scale
Standard Deviation 6.35
|
|
Changes in Mental Health Stress From Baseline to 6 Weeks
6-week follow-up
|
27.27 score on a scale
Standard Deviation 6.97
|
28.62 score on a scale
Standard Deviation 6.58
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff \>5 indicates poor sleep.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=111 Participants
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.
|
Allocation to Waitlist Control Group
n=285 Participants
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)
|
|---|---|---|
|
Changes in Overall Sleep Problems From Baseline to 12 Weeks
Baseline
|
8.50 score on a scale
Standard Deviation 3.02
|
8.41 score on a scale
Standard Deviation 3.35
|
|
Changes in Overall Sleep Problems From Baseline to 12 Weeks
12-week follow-up
|
7.11 score on a scale
Standard Deviation 2.77
|
7.88 score on a scale
Standard Deviation 3.50
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=111 Participants
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.
|
Allocation to Waitlist Control Group
n=285 Participants
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)
|
|---|---|---|
|
Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks
Baseline
|
2.72 score on a scale
Standard Deviation 0.63
|
2.67 score on a scale
Standard Deviation 0.73
|
|
Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks
12-week follow-up
|
2.98 score on a scale
Standard Deviation 0.74
|
2.77 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
SF 12 (PCS \& MCS): Norm based T scores (mean 50, SD 10); higher = better health status. We report PCS and MCS separately.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=111 Participants
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.
|
Allocation to Waitlist Control Group
n=285 Participants
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)
|
|---|---|---|
|
Changes in Health Measures From Baseline to 12 Weeks
Baseline physical wellbeing SF-12
|
52.88 score on a scale
Standard Deviation 6.59
|
51.22 score on a scale
Standard Deviation 8.74
|
|
Changes in Health Measures From Baseline to 12 Weeks
12-week follow-up physical wellbeing SF-12
|
53.08 score on a scale
Standard Deviation 7.78
|
51.61 score on a scale
Standard Deviation 8.75
|
|
Changes in Health Measures From Baseline to 12 Weeks
Baseline mental wellbeing SF-12
|
37.80 score on a scale
Standard Deviation 6.04
|
38.29 score on a scale
Standard Deviation 6.61
|
|
Changes in Health Measures From Baseline to 12 Weeks
12-week follow-up mental wellbeing SF-12
|
39.27 score on a scale
Standard Deviation 6.53
|
38.19 score on a scale
Standard Deviation 6.85
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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.
PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.
Outcome measures
| Measure |
Allocation to Sleep Improvement App
n=111 Participants
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.
|
Allocation to Waitlist Control Group
n=285 Participants
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)
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|---|---|---|
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Changes in Mental Health Stress From Baseline to 12 Weeks
Baseline
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28.05 score on a scale
Standard Deviation 6.18
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28.81 score on a scale
Standard Deviation 6.40
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Changes in Mental Health Stress From Baseline to 12 Weeks
12-week follow-up
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25.60 score on a scale
Standard Deviation 6.57
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27.48 score on a scale
Standard Deviation 6.71
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Adverse Events
Allocation to Sleep Improvement App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Allocation to Waitlist Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Susanne Fischer / Sr. Manager Clinical Research
Resmed Germany Inc
Phone: +491707854257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place