Sleep tracking and the potential for digital endpoints

Sleep and its importance to health is becoming a greater focus of research. With more research being published, the public is becoming more aware of sleep’s functions and there are a number of apps and devices that now allow users to gauge the quality of their rest. Ben Hargreaves uncovers why this interest in sleep could be more than a fad and might actually play a key role in research and clinical studies in the future.

There are few things more important to good health than sleep. The list of health benefits to a regular, good night’s rest is so long and the detriments of bad sleep so severe that it is a wonder that it is not prioritised more. Instead, the Sleep Foundation found that 32.6% of working adults in the US report sleeping six or fewer hours per night in 2018, an increase of 4.2% on people surveyed 10 years prior. There are studies suggesting that people today sleep one to two hours less than 50 years ago. Research in the UK found that lower productivity due to lack of sleep could be costing the economy up to £40 billion per year. To compound matters, the population demographic most at risk for lack of sleep are the older members of society who are also the most likely to have existing health problems.

For most adults, the amount of sleep needed for best health is between seven and eight hours, with some variation for individuals needing fewer or greater number of hours than this. The minor impacts of sleep insufficiency will be known by most people: slowed thinking, reduced attention span, worsened memory, poor decision-making, lack of energy, and mood changes. However, the health conditions that can arise from long-term insufficient sleep are far more serious: mental health disorders, immunodeficiency, diabetes, cardiovascular disease, obesity, hormone imbalances, and chronic pain or inflammation.

Why is sleep being discussed more?

Since 2005, the number of peer-reviewed sleep journals has more than tripled, reflecting both the increased importance placed on a sufficient level of sleep and an ability to test patients in a more convenient manner. One of the major breakthroughs in sleep research in recent times has been the ability for people to be tested, or to test themselves, at home. The improvement of technology has allowed the conditions of a clinic to be mimicked at home through portable devices. The sophistication of such devices can vary – classic polysomnography tests can be carried out through portable equipment and more simplified measurements can be recorded via smartphones or wearable devices.

The latter devices have become one of the major drivers for the growing interest in sleep as a lifestyle goal, as the amount of people owning such technology has soared. Most of these devices come with some form of sleep tracking, or else have sleep tracking applications available for download. This means that the general public is better able to measure and pay attention to the levels of sleep they are attaining each night.

The number of technological solutions aiming to improve sleep has boomed in recent years, some of which do not require the user to do anything more than download specific software. Recently, Sleepio, an app to improve sleep, was approved in draft guidance by the UK’s cost-effectiveness agency, NICE, for treating patients with insomnia. This could effectively offer 800,000 people in England an alternative form of treatment to prescription drugs.

The other core technology within this new wave is wearable sleep-trackers, with these devices being increasingly viewed as important to future research and clinical studies. One recent publication found that wearable trackers ‘compared favourably’ to actigraphy for wake detection. However, there was a caveat in these results that suggested that most commercial wearables were not suitable for determining sleep stages. Beyond these solutions, there are also a growing number of devices utilising the Internet of Things to track sleep, such as smart beds and mattresses, which are able to track sleep and adjust their position to potentially alleviate snoring.

Novel digital endpoints

The advance of all of these digital health tools has led to the development of ‘novel digital endpoints’ (NDEs) to support drug development and regulatory applications. The possibility for this type of addition to clinical studies is still being explored and is in its infancy, however, the potential benefits are clear. The advantages are most obvious in conditions linked to motor control, due to the ease with which this can be monitored through wearable devices. This means there is research on-going in areas, such as Parkinson’s disease and Duchenne Muscular Dystrophy – with the latter condition being the first to receive qualification from the European Medicines Agency to use an NDE for quantifying the ambulation ability of patients.

The potential exists for similar approaches to be taken in sleep, particularly in areas where current technologies are well-suited, such as determining sleep-wake patterns. The potential therapeutic being studied would not necessarily have to be focused on a sleeping condition, but could be targeting other conditions where an improvement to sleep could lead to an overall improvement in quality of life.

There is a European research project underway, entitled, Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (IDEA-FAST), which is assessing the possibility for such research in neurodegenerative disorders. The work is being funded by the European Union and the European Federation of Pharmaceuticals Industries and Associations, with a number of individual pharma companies actively linked to the research being undertaken through this project.

The timing for this increased focus in ways to improve and to track sleep comes as a new wave of pharmaceutical treatments have recently hit the market. The ‘orexin’ drugs, currently comprised of Merck’s Belsomra (suvorexant), Eisai’s Dayvigo (lemborexant) and Quviviq (daridorexant), have all been approved recently in the US and most recently the latter treatment in Europe. The treatments are expected to reach blockbuster status and, if they manage to do so, this could spur greater investment into the space. Though the development of sleep-tracking technology came too late to aid the approvals of the orexin wave of treatments, it seems a strong possibility that the next-generation of treatment could be employing NDEs to support regulatory submissions.