The Effects of a Personalized Sleep Improvement App From SleepScore Labs

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior
• Intervention / Treatment: Behavioral: Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore

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 Type: Interventional
• Enrollment (Actual): 637
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45239
      • Ruhrlandklinik Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Behavioral: 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. 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.; Other Names: SleepScore Mobile App; Dein Schlaf. Dein Tag. App
No Intervention: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: SleepScore Labs International LTD
• Investigators: Principal Investigator: Christoph Schoebel, Prof, Ruhrlandklinik Essen

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sleep; Smartphone Application; Preventative Health
• Additional Relevant MeSH Terms: Behavior; Health Behavior
• Other Study ID Numbers: 20211202DSDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD as data analysis will be conducted internally and raw IPD will not be shared with external researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No