CUPERTINO, Calif. — Apple on Monday announced a new Apple Watch feature that will warn users they may have sleep apnea. It’s the latest advance in the company’s decade-long effort to sell its wearable as a tool that can help people live healthier lives.
Additionally, the company announced more hearing health features for its wireless earbuds. The company’s AirPods will be able to conduct a hearing test and later this fall will be able to be used as a “clinical grade over-the-counter hearing aid,” Apple’s vice president of health Sumbul Desai said in a prerecorded announcement video.
The new sleep apnea feature will use the watch’s onboard sensors to detect the dangerous sleep disorder in which people have interrupted breathing. At least 25 million Americans suffer from the condition that can result in daytime tiredness and increases the risk of cardiovascular disease and other negative health outcomes. However, it remains unclear how this new feature will fit into or modify the clinical practice of sleep medicine — an ongoing challenge for the data generated by wearables.
The feature monitors users for disturbances while they are sleeping, and warns users with “signs of moderate to severe sleep apnea,” said Desai. The feature will provide education materials and a detailed report that can be shared with a doctor.
Desai said that the algorithm was developed using machine learning with an “extensive data set of clinical grade sleep apnea tests.” Then, the algorithm was validated in “clinical study unprecedented in size for sleep apnea technology,” said Desai. No additional information about this clinical work was immediately available.
Desai said the company expects clearance from the Food and Drug Administration for the sleep apnea feature “very soon” and that the feature would be available on new Apple Watches and the 2023 Series 9 in September. She also said an FDA clearance for the hearing aid technology was forthcoming.
Christine Lemke, the CEO of consumer health data company Evidation Health, said that a wearable’s sensors are probably best suited to screening rather than definitive diagnosis.
Still, she said, “It’s impactful to receive a proactive alert to explore this more with your physician. This seems like a moment in time where the sensors are good enough to provide valuable information for pre-screening purposes.”
Seema Khosla, medical director at North Dakota Center for Sleep, agreed that the feature looked promising. However, she pointed out that sleep apnea does not have the same physical markers in all people. For example, some people with the condition may not have low blood oxygen and may have sleep readings that present as normal.
“This may be an extremely important screening tool as long as we understand what it can and cannot do — which questions it can and cannot answer,” she said. “This may be an important piece of data that at least triggers a conversation about sleep apnea.”
Meanwhile, Vik Kheterpal, a physician and principal at CareEvolution, which develops technology that’s used for wearable device studies, felt that the Apple feature was part of a larger movement that could reverse troubling trends in sleep apnea treatment.
“Traditional gold standard approach to sleep apnea screening, diagnosis, and treatment occurs too infrequently, too late, and is too costly,” he said. “With the recent emphasis on sleep hygiene made possible by the rise of [over-the-counter] consumer grade wearables… we have an opportunity to push forward with innovative approaches to re-imagine how sleep apnea is addressed.”
Apple’s initial health push focused on fitness tracking but it has since launched a bevy of Apple Watch, iPhone, and AirPod features aimed at giving users more information about their health. The Apple Watch also allows people to take electrocardiograms and can detect hidden atrial fibrillation. The company has also launched features that detect people’s cardio fitness and whether they are at risk of falling from unsteady walking.
As with Apple’s other health features, sleep apnea detection comes with benefits, like helping people discover hidden health conditions, and tradeoffs. Many of these features point people toward a health care system that may not be prepared for them.
“These enhanced screening tools always sound good,” said Joseph Ross, a professor at Yale Medical School who is completing a study of the Apple Watch in clinical practice. “But the reality is a bit more complicated. How many people [are]screening positive? Of those, how many really have the problem? What is the impact in terms of subsequent health care utilization and costs? What is the impact in terms of consumer worry and anxiety while they await more traditional clinical screening? It’s all a fine balance.”
Kheterpal agreed that over-diagnosis is always a concern with such technologies. But he pointed out that the concern with false positives may not be as grave with sleep apnea as with screenings for prostate or breast cancer, where a positive screen can result in an invasive biopsy. A sleep study to diagnose sleep apnea is low-risk, if potentially costly.
“Given the harm we are realizing each day with the systemic under-diagnosis, we need to reset our biases and have a bias to action in the case of sleep apnea,” he wrote. (CareEvolution worked with Apple on a study of an asthma intervention.)
Apple is not the first to market here. Samsung earlier received Food and Drug Administration clearance for a feature that allows the company’s Galaxy Watch to detect sleep apnea. And the FDA has cleared a number of other devices that allow people to screen themselves for sleep disorders. Google-owned Fitbit has explored sleep apnea tech in the past.
The company did not specify what sensors are used in the sleep apnea feature. The feature from Samsung uses pulse oximetry technology. Apple is currently prohibited from selling similar tech in the United States after a court ruled that Apple had infringed on patents from medical device company Masimo.
Sleep tracking is a key feature for wearable devices and Apple has introduced a steady drumbeat of developments in recent years. In 2017, Apple acquired Beddit, a company that developed a sleep tracking mat.