Clinical trial NCT05195359: The Effects of a Personalized Sleep Improvement App From SleepScore Labs
Official title: The Effects of a Personalized Sleep Improvement Smartphone Application From SleepScore Labs: A Single-blinded Randomized Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: Sleep
Smartphone Application
Preventative Health
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: SleepScore Labs International LTD
First posted: 2022-01-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded Randomized Waitlist Controlled Trial
Primary purpose: PREVENTION

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 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.

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 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 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

Primary outcomes:
measure: Changes in subjective sleep quality between active sleep-change condition through the Dein Schlaf. Dein Tag. App and the waitlist condition comparing baseline with 6 weeks and 12 weeks measures.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in overall sleep problems.
timeFrame: 12-weeks
measure: Changes in feeling of being refreshed in the morning.
timeFrame: 12-weeks
measure: Changes in health measures.
timeFrame: 12 weeks
measure: Changes in mental health stress.
timeFrame: 12 weeks
measure: Recorded sleep parameters (only app condition).
timeFrame: 12 weeks
measure: Self-reported app-based health measures(only app condition).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
state: Northrhine-Westphalia
Study officials:
affiliation: Ruhrlandklinik Essen
name: Christoph Schoebel, Prof
role: PRINCIPAL_INVESTIGATOR
References: