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NCT05195359

The Effects of a Personalized Sleep Improvement App From SleepScore Labs

Completed NA Results posted Last updated 26 November 2025
What this trial tests

NA trial testing Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore in Health Behavior in 637 participants. Completed in 15 August 2023.

Timeline
31 January 2023
Primary endpoint
15 August 2023
15 August 2023

Quick facts

Lead sponsorResMed
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment637
Start date31 January 2023
Primary completion15 August 2023
Estimated completion15 August 2023
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

ResMed — full company profile →

Who can join

18 and older, any sex, with Health Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in SF B Sleep Quality From Baseline to 6 Weeks Primary · Baseline and 6 weeks

SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App2.73± 0.51
Allocation to Waitlist Control Group2.73± 0.56
6-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App2.98± 0.51
Allocation to Waitlist Control Group2.81± 0.60
Change in SF B Sleep Quality From Baseline to 12 Weeks Primary · Baseline and 12 weeks

SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App2.75± 0.50
Allocation to Waitlist Control Group2.73± 0.56
12-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App3.05± 0.51
Allocation to Waitlist Control Group2.86± 0.64
Changes in Overall Sleep Problems From Baseline to 6 Weeks Secondary · Baseline and 6 weeks

PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff \>5 indicates poor sleep.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App8.54± 3.02
Allocation to Waitlist Control Group8.47± 3.37
6-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App7.14± 2.65
Allocation to Waitlist Control Group8.24± 3.57
Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks Secondary · Baseline and 6 weeks

SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App2.68± 0.63
Allocation to Waitlist Control Group2.68± 0.77
6-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App2.86± 0.70
Allocation to Waitlist Control Group2.75± 0.78
Changes in Health Measures From Baseline to 6 Weeks Secondary · 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.

Baseline physical wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App52.70± 6.62
Allocation to Waitlist Control Group51.01± 8.76
6-week follow-up physical wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App53.13± 8.09
Allocation to Waitlist Control Group50.45± 9.11
Baseline mental wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App37.31± 6.15
Allocation to Waitlist Control Group38.16± 6.68
6-week follow-up mental wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App38.56± 7.16
Allocation to Waitlist Control Group38.77± 6.69
Changes in Mental Health Stress From Baseline to 6 Weeks Secondary · Baseline and 6 weeks

PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App28.62± 6.34
Allocation to Waitlist Control Group28.87± 6.35
6-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App27.27± 6.97
Allocation to Waitlist Control Group28.62± 6.58
Changes in Overall Sleep Problems From Baseline to 12 Weeks Secondary · Baseline and 12 weeks

PSQI Global Score: Range 0-21; higher = worse sleep quality; conventional cutoff \>5 indicates poor sleep.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App8.50± 3.02
Allocation to Waitlist Control Group8.41± 3.35
12-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App7.11± 2.77
Allocation to Waitlist Control Group7.88± 3.50
Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks Secondary · Baseline and 12 weeks

SF B Feeling Refreshed (GES): SF B GES subscale. Range 1-5; higher = better feeling of being refreshed.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App2.72± 0.63
Allocation to Waitlist Control Group2.67± 0.73
12-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App2.98± 0.74
Allocation to Waitlist Control Group2.77± 0.78
Changes in Health Measures From Baseline to 12 Weeks Secondary · 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.

Baseline physical wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App52.88± 6.59
Allocation to Waitlist Control Group51.22± 8.74
12-week follow-up physical wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App53.08± 7.78
Allocation to Waitlist Control Group51.61± 8.75
Baseline mental wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App37.80± 6.04
Allocation to Waitlist Control Group38.29± 6.61
12-week follow-up mental wellbeing SF-12
GroupValue95% CI
Allocation to Sleep Improvement App39.27± 6.53
Allocation to Waitlist Control Group38.19± 6.85
Changes in Mental Health Stress From Baseline to 12 Weeks Secondary · Baseline and 12 weeks

PSS 10: 10 items scored 1-5; total 10-50; higher = more stress.

Baseline
GroupValue95% CI
Allocation to Sleep Improvement App28.05± 6.18
Allocation to Waitlist Control Group28.81± 6.40
12-week follow-up
GroupValue95% CI
Allocation to Sleep Improvement App25.60± 6.57
Allocation to Waitlist Control Group27.48± 6.71

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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