FDA approves Apple's sleep apnea detection characteristic to be used

Tim Cook, CEO of Apple Inc., during an event at the Apple Park campus in Cupertino, California, U.S., on Monday, Sept. 9, 2024. Apple Inc. unveiled a new version of its smartwatch with a larger screen and the ability to detect sleep apnea at an event Monday where it will also unveil the iPhone 16 smartphone. Photographer: David Paul Morris/Bloomberg via Getty Images

Bloomberg | Bloomberg |

The US Food and Drug Administration on Monday deleted AppleThe new sleep apnea detection feature has been approved for use and is now available via a software update for Apple Watch Series 9, Series 10 and Ultra 2 users.

Sleep apnea is a sleep disorder in which a person's breathing repeatedly stops and starts throughout the night. According to the American Medical Association, the condition affects over 30 million people in the United States, but only about 6 million are diagnosed. If left untreated, sleep apnea can cause fatigue and lead to more serious health problems, such as heart problems, high blood pressure, and type 2 diabetes.

“We are so excited about the incredible impact this feature can have for the millions of people living with undiagnosed sleep apnea,” said Dr. Sumbul Desai, Apple’s vice president of health, in the feature’s launch video.

Apple's sleep apnea detection feature is the company's latest attempt to position its wearables as a cheaper, simpler alternative to many existing health tests and devices. And the market for sleep disorders could prove lucrative.

To be screened for sleep apnea, for example, patients typically take a home test or a lab test where they are monitored overnight. Prices vary depending on insurance coverage, but the average lab test costs $3,000, according to a 2022 study in the Journal of Primary Care & Community Health.

At-home tests are often less expensive, but can still cost hundreds of dollars. For example, Sleep Doctor's at-home sleep apnea test costs $189. Apple's newest watch, the Series 10, starts at $399.

Apple's sleep apnea detection feature is “potentially a game changer” for patients who have previously been hesitant to get tested, said Dr. David Kuhlmann, a physician who has treated sleep disorders in Missouri for nearly two decades. Kuhlmann is also a board member of the American Academy of Sleep Medicine, a professional association for sleep medicine specialists.

Kuhlmann said the feature could be especially helpful for patients who sleep alone, and he believes many people will be surprised to find they are experiencing signs of sleep apnea.

Still, users should view Apple's sleep apnea data with caution because the readings could be inaccurate, Kuhlmann said. He said it's unlikely that insurance companies would start paying for sleep apnea therapies like CPAP machines based on Apple Watch data alone, so it's important that patients contact their doctor for an official diagnosis.

“People need to be diagnosed to be treated,” Kuhlmann said in an interview with CNBC.

Kuhlmann said the feature will likely lead to an increase in doctor visits, which could ultimately reduce costs for the U.S. health care system overall. Ideally, patients who detect sleep apnea earlier can avoid later treatments for more serious conditions.

“By finding out if these sleep disorders exist and getting them treated, we may actually be able to save costs and improve quality of life.”

How it works

Sleep apnea alarm for Apple Watch Series 10.

Apple Inc.

Apple's sleep apnea detection feature works by analyzing a new metric the company calls “disordered breathing.” Apple Watch detects disordered breathing by using an accelerometer to measure wrist movements that indicate disruptions to the normal breathing pattern.

Users can view their nightly readings in the Health app, where they are classified as “elevated” or “not elevated,” which is normal. Apple analyzes this breathing disorder data once a month and notifies users if they have “consistent signs” of severe or moderate sleep apnea. Users can view their data over a period of one month, six months, or one year.

The Apple Watch Series 10 supports 18 hours of battery life, so people who want to use this feature will likely need to charge their device during the day.

Apple may also create a report that users can take to their doctor to discuss next steps. The report will include three months of data on breathing symptoms, as well as some additional information, the company said. Users can also access educational materials within the Health app.

Apple said the notification algorithm was developed using “an extensive dataset of clinical sleep apnea tests” and the feature was validated in a clinical study.

“Now I really want an Apple [Watch] so I can try it out myself,” said Kuhlmann.

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