FDA Clears Apple’s Sleep Apnea Notification Feature

The Food and Drug Administration (FDA) has cleared the Sleep Apnea Notification Feature for the Apple Watch.

The over-the-counter medical application is intended for individuals aged 18 years and older who have not been previously diagnosed with sleep apnea. Using accelerometer data, the Apple Watch is able track breathing disturbances during sleep and notify the user of possible sleep apnea. The information is provided as a report in the Health app that can be shared with a health care provider.

The FDA clearance was supported by results from a clinical trial that analyzed data from a broad study population (N=1448) with apnea-hypopnea index values ranging from less than 5 (normal) to greater than or equal to 30 (severe sleep apnea). The performance accuracy was assessed based on the sensitivity of the notification for individuals with moderate to severe sleep apnea and the specificity of the notification for those with normal or mild sleep apnea.  

Findings showed the application was able to identify sleep apnea in study participants while minimizing the risk of false positives. The weighted overall sensitivity was 66.3% (95% CI, 62.2-70.3) and the weighted overall specificity was 98.5% (95% CI, 98.0-99.0). 

According to the FDA, Apple’s Sleep Apnea Notification Feature is not intended to diagnose, treat, or aid in the management of sleep apnea.  

This article originally appeared on MPR