Three Apple Watches To Get FDA-Approved Sleep Apnea Detection Feature with WatchOS 11

Highlights

  • watchOS 11 launches a Sleep Apnea Detection feature.
  • It uses a built-in accelerometer to monitor sleep disturbances.
  • This feature will be available on Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2.
Sleep apnea notifications come to Apple Watches with WatchOS 11. (Image Credit – Apple)

WatchOS 11 has been finally launched and it brings with it multiple enhancements to the Apple Watches. One feature that caught everyone’s attention since the time of the announcement is the Sleep Apnea Detection feature in Apple Watches. Now, watchOS 11 finally brings this feature to your wrists.

The Federal Drug Administration approved the feature just in time before the WatchOS 11 rollout.

According to reports, FDA approval came on the basis that Apple’s feature method is “substantially equivalent to methods already approved by the FDA.”

“Empowering consumers everywhere to have the ability to reliably identify the presence of abnormal breathing patterns during sleep can help uncover a woefully underdiagnosed and serious medical condition such as sleep apnea,” Sairam Parthasarathy, professor of medicine at the University of Arizona and director of Health Sciences Center for Sleep, Circadian and Neurosciences Center for Sleep, UA Health Sciences, said in a statement. “This is a major step forward in improving public health.”

“We are so excited about the incredible impact this feature can make for the millions of people living with undiagnosed sleep apnea,” Dr. Sumbul Desai, VP of Health at Apple said while introducing the upcoming Apple Watch feature.

Apple’s sleep apnea detection feature is “potentially a game changer” for patients who have been reluctant to seek out testing, said Dr. David Kuhlmann, a physician who has treated sleep disorders for nearly two decades in Missouri. Kuhlmann also is on the board of the American Academy of Sleep Medicine, which is a professional society for sleep medicine clinicians.
Kuhlmann said the feature could be helpful for patients who sleep alone, and he thinks a lot of people will be surprised to find out they’re showing signs of sleep apnea.
Kuhlmann said users should approach Apple’s sleep apnea data with some caution, as readings could be erroneous. He said it is unlikely that insurance companies will begin paying for sleep apnea therapies like CPAP machines based on Apple Watch data alone, which is why it is important for patients to follow up with their healthcare providers to get an official diagnosis.
“People do need to be diagnosed in order to be treated,” Kuhlmann told CNBC in an interview.

What is Sleep Apnea?

Sleep apnea is a serious health condition in which people suffer from breathing interruptions during their sleep. Breathing stops and starts during sleep, which although not immediately dangerous can lead to physical and mental health issues.

The most common type of this condition is obstructive sleep apnea. It occurs when the throat muscles relax and block the airway. It prevents air from reaching the lungs.

Which Apple Watches Gets the Sleep Apnea Detection Feature?

The new Sleep Apnea detection feature will be available as part of watchOS 11.

It will work on the following three Apple Watches:

  • Apple Watch Series 9
  • Apple Watch Series 10
  • Apple Watch Ultra 2

Sleep Apnea Detection Feature in Apple Watch

Sleep apnea is usually detected with the help of overnight monitoring in a sleep clinic. People have to be attached to a lot of medical equipment to be able to get a diagnosis.

Modern diagnosis also involves a simple wearable device that people can wear and stay at home. It captures the sleep pattern for a diagnosis later.

As per Apple, its Sleep Apnea detection feature instead uses the built-in accelerometer.  This monitors and detects movements indicative of sleep disturbance.

Apple explains this in detail:

“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.”

FAQs

 Which Apple Watches will support the new Sleep Apnea Detection feature in watchOS 11?

The Sleep Apnea Detection feature will be available on Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2.

How does the Sleep Apnea Detection feature in watchOS 11 work?

The feature uses the built-in accelerometer to monitor and detect movements indicative of sleep disturbances, helping to identify potential sleep apnea.

How does Sleep Apnea Notifications work on the three Apple Watches ?

Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2 now offer a feature to help identify signs of sleep apnea.

To detect signs of sleep apnea, Apple Watch uses the accelerometer to monitor small movements at the wrist during sleep that are associated with interruptions in normal respiratory patterns, tracked by a new Apple Watch metric called Breathing Disturbances.

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.

What does the Sleep apnea notification algorithm analyse on Apple Watches ?

Following an onboarding for the feature, the new sleep apnea notifications algorithm analyses breathing disturbance data every 30 days, so Apple Watch can notify a user if it identifies signs of sleep apnea.

The notification includes the time period when potential sleep apnea occurred and educational materials on the importance of seeking treatment, along with a PDF providing three months of breathing disturbance data, notification details, and additional information to reference during a conversation with a healthcare provider.

Which Sleep apnea notifications have advanced processing power of the S9 SiP and S10 SiP ?

Sleep apnea notifications use the advanced processing power of the S9 SiP and S10 SiP and scientifically validated algorithms.

The feature was developed with advanced machine learning and training data from thousands of nights of clinical-grade sleep apnea tests, and validated in the largest study ever conducted for the FDA clearance of a sleep apnea device.

Following FDA 510(k) clearance and additional global health authority authorisations, sleep apnea notifications are now available in more than 150 countries and regions, including the U.S., the EU, and Japan.

What sensor does Apple Watch use for detecting sleep apnea?

Apple Watch users the 3-axis gyroscope to detect disturbances in breathing while sleep tracking.

The blood oxygen sensor, which is disabled on newer watches in the US but otherwise available worldwide, is not used.

Support for monitoring and providing alerts when signs of sleep apnea are detected is a feature that requires regulatory approval in regions where offered.

As promised, Apple received the necessary approval for its accelerometer-based breathing disturbance monitoring in the US.

In other words, you don’t just have to take Apple’s word for it that this method works.

What does the newly published document detail about Apple Approved Sleep Apnea Detection feature work ?

Apple Watch tracks movement with triaxial accelerometer signals, which capture coarse motion of the body as well as fine movements including motion associated with breathing.

Apple developed an algorithm that uses the accelerometer time series data to classify Breathing Disturbances that occur during sleep tracking, which are temporary interruptions in the breathing pattern.

Figure 1 demonstrates the relationship of the Apple Watch accelerometer data (X, Y, and Z) alongside more traditional methods of identifying disruptions to breathing, including abdomen belts and airflow meters.

The Sleep Apnea Notification Feature contains two components: a nightly Breathing Disturbances measurement and a notification sent to the user if the Breathing Disturbances values are elevated over a 30-day period, indicating signs of potential moderate to severe sleep apnea.

Note that neither component is intended or cleared for use by people who are already diagnosed with sleep apnea. Breathing Disturbances aren’t equivalent to the AHI.

Initial use of this feature requires a short onboarding process and sleep tracking to be enabled on Apple Watch.

Once active, Breathing Disturbances values can be viewed in the Health app. Tracking Breathing Disturbances helps users understand their sleep and the behaviors or lifestyle factors that may affect their Breathing Disturbances levels.

The notification feature alerts users who may be at risk of moderate to severe sleep apnea. An example of Breathing Disturbance data viewed in the iPhone Health app is shown in Figure 2.

In this example, the majority of nights were classified as not elevated, so the displayed period is summarized as Not Elevated.

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