N/A
N=637
The Effects of a Personalized Sleep Improvement App From SleepScore Labs
Health Behavior
Bottom Line
View on ClinicalTrials.gov: NCT05195359 ↗Enrolled (actual)
637
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in SF B Sleep Quality From Baseline to 6 Weeks — 2.73; 2.73; 2.98; 2.81 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in SF B Sleep Quality From Baseline to 6 Weeks |
2.73; 2.73; 2.98; 2.81 | <0.0001 sig |
| PRIMARY Change in SF B Sleep Quality From Baseline to 12 Weeks |
2.75; 2.73; 3.05; 2.86 | 0.0003 sig |
| SECONDARY Changes in Overall Sleep Problems From Baseline to 6 Weeks |
8.54; 8.47; 7.14; 8.24 | 0.0002 sig |
| SECONDARY Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks |
2.68; 2.68; 2.86; 2.75 | 0.0606 |
| SECONDARY Changes in Health Measures From Baseline to 6 Weeks |
52.70; 51.01; 53.13; 50.45; 37.31; 38.16 | 0.2056 |
| SECONDARY Changes in Mental Health Stress From Baseline to 6 Weeks |
28.62; 28.87; 27.27; 28.62 | 0.0754 |
| SECONDARY Changes in Overall Sleep Problems From Baseline to 12 Weeks |
8.50; 8.41; 7.11; 7.88 | 0.0137 sig |
| SECONDARY Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks |
2.72; 2.67; 2.98; 2.77 | 0.0152 sig |
| SECONDARY Changes in Health Measures From Baseline to 12 Weeks |
52.88; 51.22; 53.08; 51.61; 37.80; 38.29 | 0.8148 |
| SECONDARY Changes in Mental Health Stress From Baseline to 12 Weeks |
28.05; 28.81; 25.60; 27.48 | 0.0729 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05195359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.