Bucking the Trend
Over the past century, chronic diseases have increasingly replaced acute disorders as leading causes of death in developed countries. So-called “diseases of affluence”[1] like heart disease, diabetes, and hypertension kill more Americans each year than acute conditions like pneumonia, tuberculosis, and infectious diarrhea. Today, six out of ten Americans suffer from at least one chronic disease, and almost 75% of the $3.5+ trillion spent domestically on healthcare each year goes to chronic care.
Since the mid 20th century, when scientists first began to understand the relationships between lifestyle behaviors of the present and health outcomes of the future, preventing chronic disease has been a major focus of public health. Unlike acute conditions, which are often preventable with vaccines and treatable with modern medicines, chronic diseases cannot be prevented with vaccination and may not be amenable to treatment with medications. Moreover, while acute conditions may arrive one morning and disappear the next, chronic conditions fester and worsen as unhealthy choices and harmful habits take their toll over time.
Motivated by chronic disease management shortcomings in our existing health care system, consumer technology companies have developed a number of wearable and other non-invasive devices designed to incentivize healthy behavior and track progress with quantitative metrics. The growing burden of chronic disease was the prevailing public health concern and motivation when Fitbit (2010), WHOOP (2012), Apple Watch (2015), and Oura (2016) were released. Each of these companies saw an opportunity to deploy consumer technology to prevent chronic disease by leveraging the notion of the “quantified self,” thereby allowing individuals to track aspects of their physiology and understand the effects of daily choices on their long-term health and well-being.
But this year, the unwelcome arrival of the novel coronavirus has profoundly reshaped the U.S. healthcare landscape and the context within which consumer technology companies operate. COVID-19 is already a top-3 leading cause of death in the United States, and could foreseeably become the leading cause of death for 2020 both domestically and worldwide. For the first time in 100 years, an infectious disease might once again be the leading cause of death in the United States.
This represents a substantial departure from the dominant trend in public health of developed nations over the last century. Although the shift from acute to chronic disease mortality risk has been sporadically interrupted by infectious disease outbreaks like HIV/AIDS, Ebola, SARS, and H1N1, these confined episodes pale in comparison to the extraordinary events of today. The COVID-19 pandemic – unprecedented in nature and magnitude – has reminded our chronically ill country of the threat posed by acute viral infections. As a result, predicting incident coronavirus is presently more important than preventing chronic disease.
Consequently, although originally conceived as tools for chronic disease prevention, healthcare focused consumer technology companies have been afforded the opportunity to deploy their technologies for acute disease prediction, and in doing so, improve their products, validate their accuracy, and take greater responsibility for public health. Indeed, the COVID-19 pandemic has broadened opportunities for consumer medical technology companies seeking to capture and reorganize the healthcare industry along a preventive care paradigm powered by remote monitoring, predictive analytics, and telemedicine. And sleep, traditionally under-appreciated and historically uncharted, is key to reconstructing a healthcare system defined by prevention not treatment.
Setting the Stage
For all the grief and suffering “unprecedented,” lethal events like COVID-19 impose, such disruption offers the opportunity to rethink, redesign, and reconstruct established structures, systems, and status quos. These interruptions captivate, provoke, and ultimately spur action (often deregulatory, sometimes hasty) by government organizations seeking all possible solutions.
In early March, President Trump signed the Coronavirus Preparedness and Response Supplemental Appropriations Act, waiving restrictions on Medicare reimbursement of telemedicine services. Reimbursement claims per week surged, 100x the volume of a month prior. Later that month, as the virus was picking up steam in New York and elsewhere across the country, the FDA issued a new policy allowing “manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely.” In doing so, the FDA hoped to extend the reach of the healthcare system – predicted to strain with an influx of COVID-19 patients – out of the clinic and into the home, thus keeping healthy people out of and away from hospitals which would likely need to be reserved for patients infected with coronavirus. Furthermore, earlier this June, the FDA expanded their guidance to include, among other digital tools, “Clinical Decision Support Software for Monitoring related to COVID-19 and Co-existing Conditions,” specifically noting algorithms that compare vital signs obtained via consumer monitoring devices with clinical guidelines in order to recommend diagnostic tests, investigations, or care. These policy decisions have given wearable and non-invasive remote-monitoring device manufacturers the green light to develop predictive tools for acute disease prevention. This “all hands on deck” approach by the FDA has finally embraced the potential of consumer medical technology to improve individual and population health.
To wit, a few weeks ago the NBA sent an exhaustive 113-page memo to the league outlining health and safety protocols for restarting the season, including strict guidelines dictating life inside the Disney World “bubble” where players and coaches will play, live, and sleep for the remainder of the season. The protocols, implemented to limit the spread of COVID-19, range from silly – stop fiddling with mouthguards – to serious – confinement to “Isolation Housing” for anyone who tests positive for the virus. While many of these measures are widely accepted by medical professionals and epidemiologists as best-practice methods to prevent the spread of coronavirus, one of the new protocols garnered significant attention on Twitter and in the press: player use of Oura ring sleep trackers to predict the onset of COVID-19.
Players traveling to Orlando will be asked to wear Oura rings, rings fabricated from titanium and equipped with physiological sensors to track sleep. The interior surface of the ring includes an infrared photoplethysmography (PPG) sensor that tracks respiration and heart rate, a negative temperature coefficient thermistor that tracks body temperature, and a 3D accelerometer that tracks movement. These sensors gather biometric inputs which can then be plugged into algorithms – “Clinical Support Software” as defined by the FDA – to determine an “illness probability score,” alerting both the player and their team when medical examination is advised. A number of studies testing and improving these predictive models and others are underway at institutions including Scripps, UCSF, UCSD, and WVU Rockefeller Neuroscience Institute.
The deployment of Oura rings to fight the spread of the pandemic in the NBA attracted a range of responses from sports, media, and medical technology professionals. Many questioned the accuracy of the ring’s biometric sensors, doubting the ability of the device to accurately measure the user’s heart rate, temperature, and sleep patterns. And even if the Oura ring can accurately gather players’ biometric data, can machine learning algorithms actually predict the onset of coronavirus? To a public weary of false promises from healthcare technology marketing executives, detecting viral infection in the midst of a global pandemic using software and wearable data seems like yet another PR play. These critics argue that many of the studies published on the ability of various models to predict infection have been funded by the device manufacturers themselves and that the FDA has yet to approve any wearable device or software application as a COVID-19 diagnostic.
Players have also weighed in on the rings, concerned for their personal privacy. Lakers forward Kyle Kuzma tweeted, “Look like a tracking device” while Nets point guard Spencer Dinwiddie asked, “Does Adam silver [sic] wear one with us while we’re all in there?” The NBA, however, has clarified that player usage is completely voluntary, rings will not be used in game, and teams will only have access to player data in the case that a player registers an elevated “illness probability score.”
Accuracy and privacy concerns regarding the NBA’s deployment of the ring are warranted, if not unique to the present. These concerns parallel ongoing debates in the sleep science community regarding the ability of sleep trackers like the Oura ring to accurately measure sleep and securely manage personal data. For years, sleep medicine and the Academies governing sleep science have scrutinized and challenged the accuracy of consumer sleep technologies. Polysomnography (PSG), the “gold standard” method of tracking sleep, monitors a range of body functions, including brain activity via EEG, eye movements via EOG, muscle activity via EMG, heart activity via ECG, pulse oximetry, respiratory effort, limb movements, and air flow. To many in the sleep science community, no consumer device or software platform could possibly rival the accuracy of clinical PSG.
While these concerns are not new, the use of Oura rings by basketball’s premier league has elevated the significance of such devices and their potential impact on the future of healthcare. Just a few days ago another professional sports league, the PGA Tour, followed suit with the NBA in announcing the deployment of consumer monitoring devices – in this case WHOOP straps – to PGA Tour players, caddies, and essential workers as part of ongoing efforts to prevent coronavirus on the Tour. Golfer Nick Watney recently tested positive for COVID despite showing no symptoms after he noticed unusual respiratory data from his WHOOP and proactively sought clinical testing.
Thus, regardless of the objective accuracy of these devices, they have now been endorsed by professional sports and will increasingly feature on the fingers and wrists of global celebrities like Giannis Antetokounmpo, LeBron James, and Rory McIlroy. This spotlight both normalizes their usage and validates their medical benefits in the eyes of the public. Furthermore, usage by professional athletes “raises the stakes” by greatly expanding the visibility of whatever outcome occurs. Success stories such as the Nick Watney case can go viral and provide significant, positive media coverage, but hardware or software failures will be illuminated for the world to see and cannot simply be buried in an academic journal.
The historical moment in which we find ourselves presents an opportunity for consumer medical technology companies to demonstrate the value of their products by saving lives in the short term, and in doing so, secure a larger role in the provisioning of public healthcare in the long term. And, as we’ve come to learn, the most valuable technologies are those whose primary focus is sleep, not wake.
Opening the Gates
Uniquely “modern” aspects of our society – globalized economies, population density, science skeptics, content reinforcement algorithms, decaying communities – have provided the ideal conditions for a novel coronavirus to take root. Acting like autobahns for COVID-19 transmission, the fault lines of our fractured nation have facilitated politicization of public health and promoted viral spread. And unfortunately, our underlying chronic medical conditions have offered easy targets to a lethal virus.
As we increasingly learn, those with pre-existing medical conditions have an increased risk of severe illness and death from COVID-19. One large study using data from New York’s outbreak found that patients with chronic conditions like kidney disease, COPD, obesity, Type 2 diabetes, and heart disease were 12 times more likely to die from COVID-19 than those without pre-existing conditions. It seems those whose health are most at risk in the long term are also most at risk in the short term.
In today’s America, that means that the virus has unduly affected socially disadvantaged communities, racially marginalized populations, and vulnerable, “essential” workers. These demographic cohorts have borne the brunt of the pandemic burden, suffering significantly higher rates of infection, hospitalization, and mortality.
By now, this uniquely American pandemic narrative is well established (at least outside of alt-right circles): contemporary problems have accelerated the spread of a virus that is most lethal to those with chronic diseases and who are most likely to be socially disadvantaged. Yet until recently, this narrative has overlooked and underappreciated the critical juncture at which these features of the pandemic converge: sleep.
Unhealthy sleep is a uniquely modern characteristic of our society. The introduction of the incandescent lightbulb in 1879 reshaped the temporal fabric of our society, enabling activity to take place at all hours regardless of the presence of natural light. As the nature of work has shifted from manufacturing to “neurofacturing,”[2] sleep has come under further pressure and for many has been marginalized. New technologies enable 24/7 productivity to an extent beyond just electric lighting. Today, insufficient sleep is a public health epidemic: 75% of Americans suffer from recurring sleep issues, 50% of Americans suffer from sleep issues each week, and 33% of Americans sleep less than 6 hours each night.
These sleep issues correlate with, contribute to, and cause a range of chronic health conditions that increase the risk of severe illness and death from COVID-19. Sleep disorders are common in individuals with chronic kidney disease, and findings suggest that short and poor-quality sleep are risk factors for chronic kidney disease progression. Sleep deprivation has been shown to be a causal factor of obesity, and 86% of obese patients with Type-2 diabetes also suffer from Obstructive Sleep Apnea. Unhealthy sleep has been linked to increased blood pressure, hypertension, heart disease, and mental illness. The nascent field of sleep science increasingly finds that sleep plays a critical role in maintaining corporeal and mental wellness and preventing chronic disease.
Unfortunately, the burden of unhealthy sleep is not distributed equally across society; socially disadvantaged populations are the most likely to be sleep impaired. Educational status and income are both inversely correlated with short sleep – those with higher incomes and more advanced degrees are more likely to get ample sleep. Racial minorities – African-Americans in particular – are more likely to be sleep-deprived: white women get an average of 6.7 hours of sleep while black men only get an average of 5.1 hours. Neighborhood deprivation, characterized by high crime rates, noisy environments, and suboptimal sleep environments contributes mightily to these “sleep disparities.” Unhealthy sleep facilitates negative feedback loops that hinder social advancement for disadvantaged populations.
The social variables at play in the epidemiology of the current pandemic are obviously multifaceted and complex. But nevertheless, COVID-19 has been most damaging to socially disadvantaged populations with pre-existing medical conditions – the exact same communities that are also most likely to be sleep-deprived. Sleep, or more accurately lack of it, along with its varying social determinants, needs to be considered as a major factor in the social epidemiology of the pandemic.
The confluence of contemporary challenges, healthcare trends, and social disparities, along with the current epidemic of unhealthy sleep, encapsulates flaws in our current healthcare system and epitomizes structural failures enabling the viral outbreak. It also vividly demonstrates why healthy sleep is the perfect platform on which to develop the consumer medical technology vision of personalized, predictive, and preventive healthcare.
Accounting for a third of each of our lives and affecting all aspects of our day, including our health, wellness, happiness, productivity, and safety, sleep serves as a means of access into homes, schools, businesses, and healthcare systems, and furthermore, provides fertile territory for emerging technologies to be developed and applied to other fields. Sleep is required literally each night, unlike fitness and nutrition which can be postponed for quite some time without acute reactions. Consistent, ample, quality sleep is perhaps the single most important determinant to our short- and long-term health across our lifespan. And now, because of a global pandemic, we are becoming increasingly aware of it.
The enrollment of consumer sleep tracking devices by the NBA and PGA as tools for acute disease prediction has brought sleep to the fore. Oura’s motto is “Better lives through better sleep.” WHOOP’s is “The world’s most powerful recovery and training tool.” The top two paid results for sleep tracking on Google are WHOOP and Oura, respectively. Let’s be very clear – these devices are first and foremost designed to track sleep.
These companies, and the rest of the consumer sleep technology space, now just need to execute on their promise. Forced into action by the ongoing pandemic, regulatory organizations have unlocked the gates for disruptive innovation. Desperate for any potentially season-saving tool, professional sports leagues have magnified the spotlight and intensified public scrutiny. And with both lives and fortunes on the line, the stakes have never been higher.
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[1] A misnomer, since these diseases disproportionately affect socially and economically disadvantaged populations. However, the term speaks to international differences, not intranational disparities.
[2] Value creation though knowledge work rather than physical labor.