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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
637
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.
Ruhrlandklinik Essen
Essen, North Rhine-Westphalia, Germany
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
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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
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