The Effects of a Personalized Sleep Improvement App From SleepScore Labs

Health Behavior Clinical Trial

Official title:

The Effects of a Personalized Sleep Improvement Smartphone Application From SleepScore Labs: A Single-blinded Randomized Waitlist Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195359
• Other study ID #: 20211202DSDT
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: August 2023

Study information

• Verified date: March 2023
• Source: ResMed
• Contact: Elie Gottlieb, PhD
• Phone: (858) 299-8995
• Email: Elie.gottlieb[@]sleepscorelabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore
The Dein Schlaf. Dein Tag. application powered by SleepScore is a validated sleep measurement application using sonar technology that also provides evidenced-based sleep advice and sleep education content based on a user's objectively measured nightly sleep data. As participants engage with the app, the Dein Schlaf. Dein Tag. application provides personalized and dynamic sleep content and sleep and circadian rhythm improvement advice based in the principles of sleep hygiene, sleep-circadian science, and cognitive behavioral psychology. Participants will also receive personalized sleep challenges tailored to improve their sleep and circadian rhythms. Each challenge lasts for 7 tracked nights, ranging from optimizing sleep habits to limiting caffeine intake, and more. Additional sleep improvement features embedded within the app include sleep sanctuary bedroom checks, sleep sounds, smart alarms, bedtime reminders, and sleep education blogs and science content.

Locations

Country	Name	City	State
Germany	Ruhrlandklinik Essen	Essen	Northrhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	SleepScore Labs International LTD

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Self-reported outcome sleep quality measures are those collected using the Sleep Quality score (SQ) of the SF-B (9 Items). The SQ can vary from 1 (very low) to 5 (very good).; The investigators will analyze between-group differences at each time-point using established statistical tests (t-test for normally distributed data, Mann Whitney-U test for non-normally distributed data).	12 weeks
Secondary	Changes in overall sleep problems.	Overall self-reported sleep problems are collected using the Pittsburgh Sleep Quality Index (PSQI), which yields a global score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality, whereby the higher the score, the worse the quality.; The investigators will analyze between-group differences at each time-point using a t-test if normally distributed, or the Mann Whitney-U test for non-normally distributed continuous data.	12-weeks
Secondary	Changes in feeling of being refreshed in the morning.	Self-reported feeling of being refreshed in the morning is collected using the Schlaffragebogen B (SF-B). The score for feeling of being refreshed in the morning (GES) can vary from 1 (very low) to 5 (very good).; The investigators will analyze between-group differences at each time-point using a t-test if normally distributed, or the Mann Whitney-U test for non-normally distributed continuous data.	12-weeks
Secondary	Changes in health measures.	Self-reported health measures are collected using the Short Form 12 Health Survey Questionnaire (SF-12), which yields a global score of 0-100. A global score of 0 indicates maximum disability and a score of 100 is equivalent to no disability.; The investigators will analyze between-group differences at each time-point using a t-test if normally distributed, or the Mann Whitney-U test for non-normally distributed continuous data.	12 weeks
Secondary	Changes in mental health stress.	Self-reported mental health stress is collected using the Perceived Stress Scale (PSS). Scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.; The investigators will analyze between-group differences at each time-point using a t-test if normally distributed, or the Mann Whitney-U test for non-normally distributed continuous data.	12 weeks
Secondary	Recorded sleep parameters (only app condition).	Recorded objective sleep outcome measures are those collected daily using the sonar-based sleep measurement application with the same units of measure (sleep-wake in minutes) and include total time in bed (minutes), total sleep time (minutes), sleep onset latency (minutes) and wake after sleep onset (minutes). Sleep efficiency is the ratio of total sleep time divided by total time in bed, expressed as a ratio between 0-100% (higher scores indicate better sleep efficiency).; To assess the impact of the sleep change intervention, the investigators will run hierarchical regression models to quantify changes of objective sleep measures over time.	12 weeks
Secondary	Self-reported app-based health measures(only app condition).	Self-reported app-based health measures are those collected using the "Log Your Day" in the application including caffeine (cups), alcohol (glasses), sports (minutes), cigarettes (number),stress (not at all to extreme), fatigue (not at all to extreme), mood (very poor to excellent), energy (very low to very high) and focus (very poor to excellent).; To assess the impact of the sleep change intervention, the investigators will run hierarchical regression models to quantify changes of self-reported sleep measures over time.	12 weeks