Obstructive sleep apnea is very common and is associated with a variety of serious health issues, such as cardiovascular disease and diabetes. Getting a proper diagnosis is hampered by the need for patients to visit a sleep clinic and undergo a polysomnography. This gold-standard test is complicated and requires specialized staff to interpret the results. To address these issues, a company called Sunrise has developed an at-home sleep apnea test that relies on a small wearable device. The device consists of a small sensor that a user can attach to their chin when they are about to go to sleep. The sensor records movements of the jaw, which it correlates with sleep events using artificial intelligence. Sunrise has recently launched the device in the UK, and it is relatively inexpensive, starting at £49 ($66). Medgadget had the opportunity to talk to Laurent Martinot, CEO & Co-founder of Sunrise, about the technology. Conn Hastings, Medgadget: Please give us an overview of the health issues associated with sleep apnea. Laurent Martinot, Sunrise: Due to its prevalence and its link with obesity and chronic cardio-metabolic diseases, Obstructive Sleep Apnoea (OSA) is a real public health problem. OSA is primarily responsible for symptoms such as daytime sleepiness (caused by sleep fragmentation), fatigue, irritability and snoring, possibly accompanied by a feeling of suffocation or suffocation during sleep. Non-restful sleep is accompanied by difficulty concentrating, nocturia (waking up to urinate more than once per night), libido disturbances and disturbances in vigilance. OSA can also be responsible for disrupting the quality of life of spouses/bed neighbors of the sufferer. OSA is thus at the origin of a significant deterioration in the quality of life which can also be the origin of accidents at work and on the road. OSA is also associated with long-term consequences: cardiovascular morbidity and mortality (arterial hypertension, heart failure, atrial fibrillation, etc.), and metabolic (diabetes, obesity) and cognitive effects. It is described as an independent predictor of mortality. Aside from consequences for quality of life (related to low emotional and professional performance, lack of energy), sleep apnoea includes a large set of comorbidities, displayed in the below chart : Besides the health issue for the individual, sufferers of OSA also bring an additional cost to the healthcare system. OSA patients are heavy consumers of healthcare services, and due to the varied symptoms this is usually before the diagnosis of OSA is made. The cost of healthcare utilization has been shown to be significantly associated with the severity of OSA. Medgadget: How is sleep apnea, and other sleep disorders, currently diagnosed? Laurent Martinot: Undergoing a polysomnography in a sleep laboratory is considered the gold standard for the diagnosis of OSA. This diagnostic test is very complex to perform and requires specialized personnel to interpret the data (with potential inter-center variability in the quality of the diagnosis). In France, the estimated wait time for a polysomnography varies from a few weeks to several months, leading to a delay and unequal access to care for a pathology which also has very effective treatment for the patient. However, the HAS recommends “promptly registering patients suspected of OSA, presenting severe daytime sleepiness and / or severe cardiovascular or respiratory comorbidities and / or occupational activity at risk of accident”. The conditions for performing a polysomnography are long and tedious as when a polysomnography is initiated, the placement of the various sensors must be performed in either a sleep laboratory or in a doctor’s office. The patient must then either be hospitalized overnight or return home equipped with the sensors. The complex and highly specialized diagnostic process is not adapted to the prevalence of the disease and its consequences. This is why there is now a strong consensus among experts on the need to develop simplified diagnostic approaches that integrate new technologies including artificial intelligence to provide robust alternatives, on an outpatient basis, for the evaluation of sleep structure, and respiratory abnormalities. The advantages of diagnosing OSA on an outpatient basis are well established but prior to the launch of Sunrise there has been no device capable of performing the test as efficiently as the reference examination, polysomnography. Furthermore, polygraphy (a home-based lighter version of the polysomnography), which does not allow the measurement of total sleep time, can lead to an underestimation of the severity of OSA and the differentiation of respiratory events of a central or obstructive nature is limited. The new integrated digital solution Sunrise allows the diagnosis of OSA via an original mandibular sensor integrating the analysis of mandibular movements. This approach has been scientifically validated for the identification of respiratory events during sleep (apnea, central or obstructive hypopnea). This diagnostic solution also helps identify sleep fragmentation and estimate total sleep time. The interpretation is reinforced by an AI system which homogenizes the quality of the scoring of respiratory events. In a large single-center validation in 376 patients, the diagnostic performance was equivalent to that of polysomnography. The digital solution functions alongside a partnering app to guide patients, and offers the possibility of carrying out the diagnosis on an outpatient basis and the test can very easily be repeated over several nights. Its integration into practices around the world could respond to the problems encountered and considerably modify the diagnostic approach of a patient suspected of OSA, and thus accelerate its treatment. While offering a major upgrade in terms of ease of use and ergonomics, Sunrise is equivalent in precision to polysomnography. Such clinical precision is quite new for a device that weighs only 3 grams and is as easy to use as a pregnancy test. Medgadget: What would lead someone to take a test for sleep apnea? Are there any warning signs that people should be aware of? Laurent Martinot: Studies show that 936 million people1 are affected by sleep apnoea – other papers concluding to a prevalence of almost 1 in 2 men aged 40 and above! -and more than 80% go undiagnosed despite adequate access to health care2. Being aware of this prevalence, knowing the long-term consequences on health and keeping in mind that sleep apnoea symptoms are quite common (see list below) is the key to prompt people to take the test. This is why we made the test so simple. Here are some of the common symptoms that can be associated with Sleep Apnoea: Loud snoring Exhaustion/tiredness on waking up Repeated awakenings and/or insomnia Choking at night Palpitations & high heart rate Frequent toilet runs during sleep (nocturia) Anxiety Mood swings Obstructive sleep apnoea is also a major risk factor for a variety of medical conditions, increasing the risk and severity of cardiometabolic diseases, including hypertension, arrhythmias, stroke, coronary heart disease, type 1 and type 2 diabetes, and metabolic dysfunction, ultimately resulting in increased overall mortality. Medgadget: Please give us an overview of the Sunrise sensor. How does it work? Laurent Martinot: The Sunrise sleep test is an AI-powered innovative 3 gram sensor that sits on the user’s chin and helps to diagnose sleep disorders and monitors for sleep disorders from the comfort of your own bedroom. Science has recently identified the most reliable signal to measure sleep. This signal comes from mandibular movements, the most direct proxy to the brain’s sleep and breathing regulation action. The real-time analysis of these mandibular movements consists of reading the activity generated by upper airway muscle contractions. This activity reflects the adjustments performed by the brain to preserve quality sleep and provides the data to allow a complete understanding of sleep events. Since it directly comes from the brain stem, the most profound and primitive part of our brain, this signal is free from the interference of complex cortex activity. To the purpose of sleep analysis, it is therefore considered as purer. The Sunrise sensor, which rests securely on the user’s chin, records data whilst the user is asleep to generate a thorough report shared the next day that highlights possible sleep apnoea or other sleep conditions through the partnering Sunrise app. Once the report is generated, users are then offered the choice to connect with sleep physicians, and receive treatment when needed. Medgadget: How is the sensor used, and how soon can it provide results? Laurent Martinot: The sensor is clinically proven and puts science at the tip of the chin, and the Sunrise sleep test can provide results after a minimum of 4 hrs of sleep. By measuring the movements in the chin, Sunrise allows everyone to perform a clinical test in a natural sleeping environment with the non-invasive small smart device and receive a thorough breakdown of the recording in just a few hours as the report is sent back at the user at sunrise. This method of results delivery means that there is no need for the user to send the device back to collect the results as the data are uploaded from the sensor to the patient’s smartphone and then to the cloud, making the results directly available for the physician to also review. Additionally, the user can then either dispose of the sensor or send it back to Sunrise through a prepaid envelope that comes with the sensor on delivery. Sunrise will then reuse the electronics and recycle the plastic body. Medgadget: How does such remote testing technology aid diagnosis and assist in limiting viral spread during the current pandemic? Laurent Martinot: Thanks to its simplicity and ergonomics, the test can be performed by the user without the need for expert support. Therefore, the user does not have to go to a sleep clinic and get in close contact with a healthcare professional to get equipped with the device. The procedure can be fully contactless and infection risk free. Coupled with the fact that the device is disposable, there is then no risk of cross contamination. Also after the test, Sunrise gets the user connected with a pool of sleep physicians, all able to perform their consultation via video call. To this extent, Sunrise is helping to limit viral spread in the context of the current pandemic. This is especially important as studies have shown patients with suspected sleep apnoea could be at higher risk if they were to contract COVID-19. (1) Benjafield et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respiratory Medicine 2019. http://dx.doi.org/10.1016/S2213-2600(19)30198-5 (2) Risk factors for obstructive sleep apnea in adults. Young T, Skatrud J, Peppard PE.JAMA. 2004 Apr 28; 291(16):2013-6. Source
