Health Behavior
Conditions
Keywords
Sleep, Smartphone Application, Preventative Health
Brief 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 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.
Interventions
BEHAVIORALDein 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. 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.
Sponsors
SleepScore Labs International LTD
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Single-blinded Randomized Waitlist Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SF B Sleep Quality From Baseline to 6 Weeks | 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 | Baseline and 12 weeks | SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Health Measures From Baseline to 6 Weeks | Baseline and 6 weeks | SF 12 (PCS & MCS): Norm based T scores (mean 50, SD 10); higher = better health status. We report PCS and MCS separately. |
| Changes in Mental Health Stress From Baseline to 6 Weeks | Baseline and 6 weeks | PSS 10: 10 items scored 1-5; total 10-50; higher = more stress. |
| Changes in Overall Sleep Problems From Baseline to 12 Weeks | Baseline and 12 weeks | PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff \>5 indicates poor sleep. |
| Changes in Overall Sleep Problems From Baseline to 6 Weeks | Baseline and 6 weeks | PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff \>5 indicates poor sleep. |
| Changes in Health Measures From Baseline to 12 Weeks | Baseline and 12 weeks | SF 12 (PCS & MCS): Norm based T scores (mean 50, SD 10); higher = better health status. We report PCS and MCS separately. |
| Changes in Mental Health Stress From Baseline to 12 Weeks | Baseline and 12 weeks | PSS 10: 10 items scored 1-5; total 10-50; higher = more stress. |
| Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks | Baseline and 12 weeks | SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed. |
| Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks | Baseline and 6 weeks | SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed. |
Countries
Germany
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 318 |
| 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) | 319 |
| Total | 637 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 124 | 34 |
Baseline characteristics
| Characteristic | Allocation to Waitlist Control Group | Total | Allocation to Sleep Improvement App |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 13 | 42 years STANDARD_DEVIATION 13 | 42 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 319 participants | 637 participants | 318 participants |
| Sex: Female, Male Female | 253 Participants | 495 Participants | 242 Participants |
| Sex: Female, Male Male | 66 Participants | 142 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 318 | 0 / 319 |
| other Total, other adverse events | 0 / 318 | 0 / 319 |
| serious Total, serious adverse events | 0 / 318 | 0 / 319 |
Outcome results
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.
Time frame: Baseline and 12 weeks
Population: All randomized participants with non missing data at the specified follow up (intent to treat completer analysis). 12 week n: App 194; Control 285.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Change in SF B Sleep Quality From Baseline to 12 Weeks | Baseline | 2.75 score on a scale | Standard Deviation 0.5 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Waitlist Control Group | Change in SF B Sleep Quality From Baseline to 12 Weeks | Baseline | 2.73 score on a scale | Standard Deviation 0.56 |
| Allocation to Waitlist Control Group | Change in SF B Sleep Quality From Baseline to 12 Weeks | 12-week follow-up | 2.86 score on a scale | Standard Deviation 0.64 |
p-value: 0.0003ANOVA
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.
Time frame: Baseline and 6 weeks
Population: All randomized participants with non missing data at the specified follow up (intent to treat completer analysis). 6 week n: App 206; Control 286.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Change in SF B Sleep Quality From Baseline to 6 Weeks | Baseline | 2.73 score on a scale | Standard Deviation 0.51 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Waitlist Control Group | Change in SF B Sleep Quality From Baseline to 6 Weeks | Baseline | 2.73 score on a scale | Standard Deviation 0.56 |
| Allocation to Waitlist Control Group | Change in SF B Sleep Quality From Baseline to 6 Weeks | 6-week follow-up | 2.81 score on a scale | Standard Deviation 0.6 |
p-value: <0.0001ANOVA
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.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | 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 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Waitlist Control Group | Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks | Baseline | 2.67 score on a scale | Standard Deviation 0.73 |
| Allocation to Waitlist Control Group | Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks | 12-week follow-up | 2.77 score on a scale | Standard Deviation 0.78 |
p-value: 0.0152ANOVA
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.
Time frame: Baseline and 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | 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 |
| Allocation to Sleep Improvement App | 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 0.7 |
| Allocation to Waitlist Control Group | Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks | Baseline | 2.68 score on a scale | Standard Deviation 0.77 |
| Allocation to Waitlist Control Group | Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks | 6-week follow-up | 2.75 score on a scale | Standard Deviation 0.78 |
p-value: 0.0606ANOVA
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.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Changes in Health Measures From Baseline to 12 Weeks | Baseline physical wellbeing SF-12 | 52.88 score on a scale | Standard Deviation 6.59 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Sleep Improvement App | Changes in Health Measures From Baseline to 12 Weeks | Baseline mental wellbeing SF-12 | 37.80 score on a scale | Standard Deviation 6.04 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 12 Weeks | 12-week follow-up mental wellbeing SF-12 | 38.19 score on a scale | Standard Deviation 6.85 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 12 Weeks | Baseline physical wellbeing SF-12 | 51.22 score on a scale | Standard Deviation 8.74 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 12 Weeks | Baseline mental wellbeing SF-12 | 38.29 score on a scale | Standard Deviation 6.61 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 12 Weeks | 12-week follow-up physical wellbeing SF-12 | 51.61 score on a scale | Standard Deviation 8.75 |
Comparison: SF-12 Physical Wellbeingp-value: 0.8148ANOVA
Comparison: SF-12 Mental Wellbeingp-value: 0.0523ANOVA
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.
Time frame: Baseline and 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Changes in Health Measures From Baseline to 6 Weeks | Baseline physical wellbeing SF-12 | 52.70 score on a scale | Standard Deviation 6.62 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Sleep Improvement App | Changes in Health Measures From Baseline to 6 Weeks | Baseline mental wellbeing SF-12 | 37.31 score on a scale | Standard Deviation 6.15 |
| Allocation to Sleep Improvement App | 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 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 6 Weeks | 6-week follow-up mental wellbeing SF-12 | 38.77 score on a scale | Standard Deviation 6.69 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 6 Weeks | Baseline physical wellbeing SF-12 | 51.01 score on a scale | Standard Deviation 8.76 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 6 Weeks | Baseline mental wellbeing SF-12 | 38.16 score on a scale | Standard Deviation 6.68 |
| Allocation to Waitlist Control Group | Changes in Health Measures From Baseline to 6 Weeks | 6-week follow-up physical wellbeing SF-12 | 50.45 score on a scale | Standard Deviation 9.11 |
Comparison: SF-12 Physical Wellbeingp-value: 0.2056ANOVA
Comparison: SF-12 Mental Wellbeingp-value: 0.4186ANOVA
Secondary
Changes in Mental Health Stress From Baseline to 12 Weeks
PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Changes in Mental Health Stress From Baseline to 12 Weeks | Baseline | 28.05 score on a scale | Standard Deviation 6.18 |
| Allocation to Sleep Improvement App | Changes in Mental Health Stress From Baseline to 12 Weeks | 12-week follow-up | 25.60 score on a scale | Standard Deviation 6.57 |
| Allocation to Waitlist Control Group | Changes in Mental Health Stress From Baseline to 12 Weeks | Baseline | 28.81 score on a scale | Standard Deviation 6.4 |
| Allocation to Waitlist Control Group | Changes in Mental Health Stress From Baseline to 12 Weeks | 12-week follow-up | 27.48 score on a scale | Standard Deviation 6.71 |
p-value: 0.0729ANOVA
Secondary
Changes in Mental Health Stress From Baseline to 6 Weeks
PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.
Time frame: Baseline and 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Changes in Mental Health Stress From Baseline to 6 Weeks | Baseline | 28.62 score on a scale | Standard Deviation 6.34 |
| Allocation to Sleep Improvement App | Changes in Mental Health Stress From Baseline to 6 Weeks | 6-week follow-up | 27.27 score on a scale | Standard Deviation 6.97 |
| Allocation to Waitlist Control Group | Changes in Mental Health Stress From Baseline to 6 Weeks | Baseline | 28.87 score on a scale | Standard Deviation 6.35 |
| Allocation to Waitlist Control Group | Changes in Mental Health Stress From Baseline to 6 Weeks | 6-week follow-up | 28.62 score on a scale | Standard Deviation 6.58 |
p-value: 0.0754ANOVA
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.
Time frame: Baseline and 12 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Changes in Overall Sleep Problems From Baseline to 12 Weeks | Baseline | 8.50 score on a scale | Standard Deviation 3.02 |
| Allocation to Sleep Improvement App | Changes in Overall Sleep Problems From Baseline to 12 Weeks | 12-week follow-up | 7.11 score on a scale | Standard Deviation 2.77 |
| Allocation to Waitlist Control Group | Changes in Overall Sleep Problems From Baseline to 12 Weeks | Baseline | 8.41 score on a scale | Standard Deviation 3.35 |
| Allocation to Waitlist Control Group | Changes in Overall Sleep Problems From Baseline to 12 Weeks | 12-week follow-up | 7.88 score on a scale | Standard Deviation 3.5 |
p-value: 0.0137ANOVA
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.
Time frame: Baseline and 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allocation to Sleep Improvement App | Changes in Overall Sleep Problems From Baseline to 6 Weeks | Baseline | 8.54 score on a scale | Standard Deviation 3.02 |
| Allocation to Sleep Improvement App | Changes in Overall Sleep Problems From Baseline to 6 Weeks | 6-week follow-up | 7.14 score on a scale | Standard Deviation 2.65 |
| Allocation to Waitlist Control Group | Changes in Overall Sleep Problems From Baseline to 6 Weeks | Baseline | 8.47 score on a scale | Standard Deviation 3.37 |
| Allocation to Waitlist Control Group | Changes in Overall Sleep Problems From Baseline to 6 Weeks | 6-week follow-up | 8.24 score on a scale | Standard Deviation 3.57 |
p-value: 0.0002ANOVA