The Effects of a Personalized Sleep Improvement App From SleepScore Labs

ResMed

Status: Enrolling

Conditions: Health Behavior

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05195359

20211202DSDT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Allocation to Sleep Improvement App

Active Comparator group

Description:

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)

Treatment:

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

Allocation to Waitlist Control Group

No Intervention group

Description:

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)