Paradigm shift in measurement technology: everyday devices open the door to medical care
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To understand the overall picture of the sleep tech industry, it is best to first look at it in four layers: measurement, diagnosis support, treatment and intervention, and environmental optimization. Of these structures, “measurement” technology has evolved the most dramatically, and is the starting point of every cycle. In modern times, smartwatches and ring-shaped ring devices have become popular rapidly and become familiar to many people. These devices quietly watch our nights with a variety of options, including contactless sensor mats for bedsides and home-use EEGs (EEGs) that are as accurate as medical devices as possible. As a result, data such as total sleep time, number of times you wake up in the middle of the night, and small variations in your heart rate and respiratory rate can be surprisingly easy and on a daily basis.
The biggest turning point in the evolution of this measurement technology is that wristwatch-type devices can now notify users of the risk of a specific disease called “sleep apnea (OSA).” In February 2024, Samsung Electronics received De Novo approval from the US Food and Drug Administration (FDA) for its ability to assess the risk of OSAs by combining its smartwatch and smartphone. This is a system that approves new medical devices that have never been seen before, meaning that as an OTC device that the average consumer can purchase without a prescription, it can now assess the potential of OSAs by simply observing just two nights of sleep data. This approval creates a new category of medical devices called “OTC devices for sleep apnea risk assessment,” and has extremely historical significance in that it paves the path to subsequent development of similar devices with similar functions.
To keep up with this move, in September of the same year, Apple also received approval from the FDA for the sleep apnea notification function (SANF) installed in the Apple Watch, which is known as 510(k) clearance, indicating its equivalent to existing medical devices. This also allows for the experience of detecting the possibility of OSA from sleep data over multiple nights and encouraging users to see a specialist on commercially available devices. What is common to both Samsung and Apple’s functions is that these are not just definitive diagnosis, but are positioned as “screening” tools that recommend visiting a medical institution. The final clinical decision is left to a doctor with expertise, and the appropriate division of roles between technology and medical care is being made. The function of bridges that connects the “awareness” emitted from everyday devices to solid “visiting” behavior is the practical key to bringing together the four layers mentioned above into one and making the entire ecosystem function.
However, there is a kind of common view among global experts in the interpretation of the data these consumer devices provide. While it is a very powerful tool for understanding long-term trends in lifestyle rhythms, such as total sleep time, time of bed and wake up, it has been pointed out that the ability to strictly determine the stages of sleep, such as light sleep, deep sleep, and REM sleep, remains inaccurate with the accuracy of overnight polysomnography (PSG), a detailed examination conducted in hospitals. Therefore, rather than just getting excited or depressed about the slightest up or down of the sleep score displayed each morning, it is recommended that users continue to use the same device, read long-term trends over weeks to months, and check what changes will occur in the data before and after interventions such as lifestyle improvements.
A smooth bridge to medical care created by home inspection
The role of home testing is the next step to helping to bring about the “maybe” realization brought about by wearable devices to a more accurate medical evaluation. This series of leads, from daily measurements to medical advice, then through home testing, to clinical evaluation, is now being established as a global standard process, regardless of region, such as North America, Europe, and Asia. In particular, the evolution of contactless devices is remarkable, with the sheet-like sensors laid under bed mattress developed by Withings of France, which obtained FDA 510(k) clearance in September 2024. This makes it possible to accurately capture unrest in breathing while sleeping, just by sleeping, and to use it as a medical device to assist in the diagnosis of OSA. Because it is easy to use at home and extremely low user burden, it is highly appreciated for its potential to significantly reduce the time it takes to screening to detect potential patients early to decide on a treatment plan.
On the other hand, in the medical field, careful discussions have been held about how much these consumer sleep technologies (CST) should be used in clinical decision-making. An important guide to this point is the official statement published by the American Society of Sleep Medicine (AASM). While acknowledging the benefits of CST such as convenience and long-term data collection capabilities, this statement also provides the limitations of its accuracy and specific points to keep in mind when handling data provided by patients in clinical settings. This provides a safe guardrail for incorporating the vast amount of data generated by patients themselves into medical judgment, and reiterates the basic principle that medical grade diagnosis and treatment should be based solely on objective evaluations by specialists. This principle remains unchanged even now that OSA risk notifications with wristwatches have become commonplace.
Among sleep disorders, there is also a movement towards insomnia, which, along with OSA, is causing many people. First, we will review and implement correct knowledge about sleep (sleep hygiene) while keeping a record of daily behavior and sleeping environment. If no sufficient improvement is seen, digital cognitive behavioral therapy (CBT-I) is recommended as an early intervention. This is a program that modifies thought habits and behavioral habits that cause insomnia through smartphone apps, rather than face-to-face with experts. However, in severe cases where improvement is still difficult or continuous, a step-by-layer structure is common, where face-to-face therapy or drug therapy is transitioned by a specialized counselor. In particular, in the UK, the National Medical Technology Assessment Agency (NICE) highly valued certain digital CBT-I programmes (Sleepio) from a cost-effective perspective and recommended use within the framework of the Public Health Services (NHS). This has set the social foundation for widespread use in a way that is accessible to everyone. The movement has spread to North America, with multiple studies demonstrating its cost-effectiveness, and there are rapidly spreading cases in countries where companies are introducing it as employee benefits or being covered by medical insurance.
Treatment options are becoming more diverse
Even in the “treatment and intervention” phase after the diagnosis is confirmed, technological advances and scientific advances provide patients with diverse options. The standard treatment for sleep apnea (OSA) remains the same as “Continuous Positive Pressure Respiratory Therapy (CPAP)” that sends air through a mask worn on your nose while sleeping to prevent airway obstruction. However, in 2021, quality issues were discovered in CPAP equipment manufactured by the major medical device manufacturer Philips, and the event that led to a massive global recall, marking once again the importance of quality control and stable supply of medical devices worldwide. In response to this issue, in April 2024, a U.S. District Court issued a consent ruling ordering the company to implement a strict remedial plan in conjunction with the FDA. This involves ensuring patient safety as the number one priority, and requires companies to fundamentally restructure their compliance systems, and there are continuing movements in medical settings in various countries to review their supply systems and strengthen follow-up with patients.
Along with this review of existing treatments, completely new treatment options are also emerging. A historic event in the sense of an extension of the treatment was that in December 2024, tilzepatide (product name: Zepbound), a type of GLP-1 receptor agonist, was approved by the FDA as the world’s first drug treatment for moderate to severe OSA patients with obesity. Large clinical trials have shown that the drug reduces physical pressure in the upper respiratory tract, primarily by promoting weight loss, and significantly reduces the number of respiratory events such as apnea and hypopnea during sleep at a clinically meaningful level. This has opened up a whole new path for treatment for patients who have difficulty continuing CPAP treatment, and for those who want to aim not only to symptomatic treatment, but also to improve obesity, the underlying cause of the disease. In the future, discussions will begin to begin in earnest on issues such as deciding on the indications of which patients are most suitable for this new drug, how to use it in combination with existing therapies such as CPAP, and how the health insurance systems in each country will reimburse these expensive drugs.
Meanwhile, cognitive behavioral therapy (CBT-I), which does not have the risk of drug dependence, has become the first choice in international practice guidelines. And what dramatically accelerated its popularity was the implementation using the aforementioned digital technology. This can be described as the very design philosophy of “triage” that contributes to the efficiency of the entire medical system, not just the phenomenon of widespread use of treatment apps. In other words, the majority of patients with relatively mild to moderate symptoms are first cared for by an accessible, inexpensive, digital CBT-I, and refractory patients who do not improve sufficiently are properly allocated to a limited number of specialists and counselors. This is the idea of focusing rare clinical resources on patients who need them most and optimizing the entire system. These changes have also impacted business models. A multi-track business model that combines multiple revenue streams, from once mainstream devices to continuous service fees (subscription), professional coaching, referrals to medical institutions, and collaboration with insurers, is becoming mainstream. The key to success in this field is how you can seamlessly design the series of “measurement -> medical visits -> intervention -> relearning” experiences, cleverly, while aligning with national and regional regulations and insurance reimbursement systems.
Sleep Tech’s Future Diagram: A New Horizon of Contactless, AI, and Data Governance
It is thought that the next wave of evolution in the sleep tech industry will converge in three major directions.
The first directions are “non-contact” and “small miniaturization” which brings the user’s physical burden to as close as possible to zero. Non-contact measurement technology using radar installed at the bedside and pressure sensors built into the mattress has dramatically improved its resolution, allowing more precise detection of positional changes such as breathing events and rolling over while sleeping. In addition, extremely small EEGs (intra-ear EEGs) worn inside the ears have significantly less stress on wearing than traditional EEGs that attach electrodes to the scalp, and are expanding their range of applications to a variety of lifestyles, such as napping during the day and understanding the sleep status of shift workers who are forced to undergo irregular lifestyle rhythms. Currently, research is being actively carried out around the world to verify the degree of validity of the signal quality and sleep stage estimation accuracy compared to the clinical standard scalp EEG.
The second direction is “automation” and “integration” through the use of artificial intelligence (AI). By integrating AI to analyze a wide variety of biological information (multimodal data), including brain waves (EEG), acceleration sensors that capture body movements, photoelectric volume pulse waves (PPGs) that estimate blood oxygen concentrations, and acoustic data such as snoring, the trend is accelerating the trend towards estimating sleep states more robust and highly accurate, less affected by individual constitutional differences and variations in physical condition on a daily basis. As the algorithms installed in wearable devices are continuously updated through software updates, the provider of services is responsible for transparently explaining the details to both users and healthcare professionals when the definition of indicators changes or the way scores are calculated. It is essential to implement honestly to prevent misinterpretation of long-term health trends.
And the third direction is the establishment of “data governance.” Personal sleep data is extremely sensitive personal information. The national regulations, such as the European General Data Protection Regulation (General Data Protection Regulation) and the US HIPAA (Act on Health Insurance Portability and Accountability), require companies to establish strict frameworks for clear consent from the individual in the collection and use of data, rules for secondary use for research purposes, anonymization processes that prevent individuals from being identified, and interoperability with public medical records. Rather than simply viewing these regulations as costs or constraints, major players around the world are beginning to believe that properly balancing privacy protection and data utilization and clearly indicating the policy to users will be the source of trust from consumers and ultimately competitiveness.
