Overall App Summary:
Sleep Time is a popular mobile app that tracks and analyzes sleep data through body movements. However, in one study comparing the Sleep Time app (published in 2015) to overnight polysomnography (the gold standard), the app showed very poor correlation to the gold standard. The app is an early prototype with all of the function features built in – but given the published results, there remain significant concern regarding the accuracy and validity of the software algorithms. Finally, from a user perspective, the app is very data oriented and does not provide enough fodder for habit change. One of the reviewers used it for over a week and nothing new was learned after the first night.
App’s Intended Use:
Sleep Time is a mobile app downloaded by 35+MM users that tracks and analyzes sleep data through body movements. The app then uses this analysis to wake the user up during the ‘ideal time’ in the sleep cycle, using a :30 wake up algorithm. By stopping the sleep cycle during its lightest phase, the app claims that users will be more refreshed upon awaking. To generally optimize sleep, the app provides soundscapes or white noise to fall asleep, and tags (e.g., caffeine or electronics) to mark behaviors that may be disruptive to sleep. Users can analyze their sleep patterns over time, as well as measure their pulse when awake, to get a full picture of their sleep cycles.
Who’s this app most useful for?
Users who feel they need to improve their sleep habit.
How should use it?
Every night to best understand their patterns.
Is the mobile app clinically relevant? Any clinical benefits? How would you use it as a provider?
No – there are some challenges with using body movement to infer sleep stage. It is not a precise measure.
Is there any published evidence that the app actually works?
There is at least 1 publication comparing the Sleep Time app to polysomnography, the gold standard. In that study, published in 2015, the authors found that absolute parameters and sleep staging reported by the Sleep Time app (Azumio, Inc.) for iPhones correlate poorly with PSG.
REFERENCE: Bhat S, Ferraris A, Gupta D, et al. Is there a clinical role for smartphone sleep apps? Comparison of Sleep Cycle detection by a smartphone application to polysomnography. J Clin Sleep Med. 2015 Jul 15;11(7):709-15. doi: 10.5664/jcsm.4840.
Most likely exempt from FDA regulatory clearance based on MMA and General Wellness guidance.
What is the most important/ desirable feature of the app? If there’s a paid version, is it worth the upgrade?
The app has a good user interface, easy to learn and to use.
Security and Privacy
Password: No password required.
Regulatory Compliance: Likely to fall under exemption of FDA regulation as according to Mobile Medical Application guidelines