Apple and Stanford University’s giant-sized study into heart health among Apple Watch users is wrapping up. According to the researchers, the study has now entered its final phase of data collection and is due to be completed “early next year.”
In total, more than 400,000 people were enrolled in what is described as the largest screening study on atrial fibrillation ever done. It was intended to determine whether wearable devices can accurately identify irregular heart rhythms.
A press release from Stanford University notes that:
“The Food and Drug Administration announced Sept. 11 that it had cleared two mobile medical apps designed by Apple to work on the Apple Watch. One app uses data from new hardware on the Apple Watch Series 4 to take an electrocardiogram by touching the button on the side of the device. The other app uses data from an optical sensor available on the Apple Watch Series 1 and later to analyze pulse data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The Apple Heart Study involves only this second app.
‘The advantage of the app that uses the optical sensor is that it can check for an irregular pulse multiple times throughout the day in the background, without needing the user to actively engage the application,’ [Marco Perez, MD, assistant professor of cardiovascular medicine] said.”
The study was carried out using an app. It kicked off in November 2017, and was open to all Apple Watch owners in the U.S., 22-years and older, with an Apple Watch Series 1 or above. Unlike the Apple Watch Series 4, which features an electrocardiogram (EKG/ECG) heart rate monitor, this study measured heart rate using the Apple Watch’s LED sensor to detect the amount of blood flowing through the wrist.
A subset of the data gathered was used by Apple as part of its submission to the FDA for clearance of an app that analyzes pulse-rate data. Apple Heart Study investigators were reportedly aware of the submission process, although they haven’t seen the submission data.
While it will be a bit longer before we get the comprehensive findings of the study, an overview paper was recently published in the American Heart Journal.