Three Apple Watches get FDA approval for sleep apnea detection, from today

2 months ago 19

Three Apple Watches get FDA approval for sleep apnea detection | Apple Watch and iPhone alerts

Three Apple Watches have received approval for detecting sleep apnea, just in time for today’s launch of the feature in watchOS 11.

The Federal Drug Administration approval was able to be granted swiftly on the basis that the way Apple is doing it is “substantially equivalent” to methods already approved by the FDA …

The health feature will be available on the new Apple Watch Series 10, but also the older Series 9 and Ultra 2.

What is sleep apnea?

Sleep apnea is a potentially serious disorder in which your breathing is interrupted while sleeping. Although these interruptions are too brief to be dangerous in themselves, they disrupt sleep, which is associated with both physical and mental health risks.

The most common form is known as obstructive sleep apnea, which is when the throat muscles collapse and block the flow of air into the lungs.

Sleep apnea detection with the Apple Watch

Traditionally, sleep apnea is detected by an overnight stay in a sleep clinic while hooked up to a variety of instruments. Alternatively, suspected sufferers can be given a simpler device to wear overnight at home, with the results captured for later diagnosis.

The Apple Watch instead uses the built-in accelerometer to detect movements indicative of sleep disturbance. Here’s what Apple says about it:

Sleep is an important area of health as it impacts a person’s overall physical and mental wellbeing. Sleep apnea is a prevalent disorder in which breathing momentarily stops during sleep, preventing the body from getting enough oxygen. The condition is estimated to impact more than 1 billion people worldwide, and in most cases, goes undiagnosed. If left untreated, it can have important health consequences over time, including increased risk of hypertension, type 2 diabetes, and cardiac issues.

Breathing Disturbances is an innovative new Apple Watch metric that uses the accelerometer to detect small movements at the wrist associated with interruptions to normal respiratory patterns during sleep. Every 30 days, Apple Watch will analyse breathing disturbance data and notify users if it shows consistent signs of moderate to severe sleep apnea so they can speak to their doctor about next steps, including potential diagnosis and treatment.

Because overall quality of sleep is important, Breathing Disturbances can also be used to assess restfulness of sleep. Breathing Disturbances can be influenced by alcohol, medications, sleep position, and more. Users can view their nightly Breathing Disturbances in the Health app, where they are classified as elevated or not elevated, and can be viewed over a one-month, six-month, or one-year period.

For more informed conversations with their healthcare providers, users can export a PDF that shows when sleep apnea may have occurred, three months of breathing disturbance data, and additional information. Educational articles are also available within the Health app to help users learn more about sleep apnea.

The sleep apnea notification algorithm was developed using advanced machine learning and an extensive data set of clinical-grade sleep apnea tests. The feature was then validated in a clinical study — unprecedented in size for sleep apnea technology. In the clinical validation study, every participant identified by the algorithm had at least mild sleep apnea.