Status:
COMPLETED
The Effects of a Personalized Sleep Improvement App From SleepScore Labs
Lead Sponsor:
ResMed
Collaborating Sponsors:
SleepScore Labs International LTD
Conditions:
Health Behavior
Eligibility:
All Genders
18+ years
Phase:
NA
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 improvemen...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2023
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT05195359
Start Date
January 31 2023
End Date
August 15 2023
Last Update
November 26 2025
Active Locations (1)
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1
Ruhrlandklinik Essen
Essen, North Rhine-Westphalia, Germany, 45239