Overview
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.
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.
Eligibility
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