The Effects of a Personalized Sleep Improvement App From SleepScore Labs

NCT05195359 | Completed Results

• 1 other identifier: 20211202DSDT
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

Sleep; Smartphone Application; Preventative Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Changes in Overall Sleep Problems From Baseline to 6 Weeks

  Baseline and 6 weeks

• Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks

  Baseline and 6 weeks

• Changes in Health Measures From Baseline to 6 Weeks

  Baseline and 6 weeks

• Changes in Mental Health Stress From Baseline to 6 Weeks

  Baseline and 6 weeks

• Changes in Overall Sleep Problems From Baseline to 12 Weeks

  Baseline and 12 weeks

Study Arms (2)

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)

Behavioral: Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore

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)

Interventions

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.

Also known as: SleepScore Mobile App, Dein Schlaf. Dein Tag. App

Allocation to Sleep Improvement App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead
• SleepScore Labs International LTD: collaborator

Study Sites (1)

Ruhrlandklinik Essen

Essen, North Rhine-Westphalia, 45239, Germany

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Susanne Fischer / Sr. Manager Clinical Research
• Organization: Resmed Germany Inc

susanne.fischer@resmed.de

+491707854257

Study Officials

• Christoph Schoebel, Prof

  Ruhrlandklinik Essen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-blinded Randomized Waitlist Controlled Trial

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 19, 2022
• Study Start: January 31, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)