Repeatedly suffocate in sleep! Why is the disease that plagues 170 million Chinese people not taken seriously?

In 2021, unable to bear the pain of sleep suffocation and awakening, 30-year-old Mr. Liu finally made up his mind to go to the hospital to see.

At first, he did not care about his "thunderous" snoring, and also called himself "sleeping soundly", until it gradually developed into frequent awakenings at night due to deep suffocation, accompanied by sweating, body twitches, arrhythmias and other symptoms. It's scary!

Under the arrangement of the respiratory doctor, Mr. Liu received PSG polysomnography monitoring all night in the monitoring ward of the Sleep Breathing Center. Through the monitoring of continuous breathing at night, arterial oxygen saturation, electroencephalogram, electrocardiogram, heart rate and other indicators, the doctor can understand whether Mr. Liu has apnea, the number of pauses, the time of suspension, the minimum arterial blood oxygen value at the time of the pause and the degree of impact on his health. It can be said that the PSG polysomnography detector is currently the internationally recognized gold standard for diagnosing OSA.

The next day, PSG monitoring reports came out, and Mr. Liu was diagnosed with severe sleep apnea - in more than 8 hours of sleep, he had more than 400 apneas, the longest time pausing for 87 seconds!

What is the concept of 87 seconds? We can try it, holding your breath in a static situation, how long can you hold out without ventilation?

The disease that plagues Mr. Liu, obstructive sleep apnea (OSA), also plagues 176 million people on the mainland. Globally, more than 1 billion people are unable to sleep well, harm their health and even endanger their lives due to sleep apnea.

Although the sleep performance of OSA patients is mainly "snoring", the degree of disease varies from person to person, and the number of apnea is as low as 30 times, more than hundreds of times, and the duration of apnea is sometimes more than ten seconds, and in severe cases, it even exceeds 2 minutes. As long as OSA patients fall asleep, they will enter the cycle of respiratory interruption - re-breathing - respiratory interruption - re-breathing, which will affect the quality of sleep, resulting in groggy and inattention during the day, and other comorbidities or complications, such as cardiovascular and cerebrovascular diseases such as hypertension or circulatory diseases such as diabetes.

21 March is the International Day of Sleep, designated by the WHO. By combing the domestic and foreign sleep breathing disorder markets, arterial network found that there are large differences between domestic and foreign markets, and many innovative enterprises focusing on sleep breathing disorder screening and management have a certain volume and have obtained FDA certification. However, in China, the fields of screening, monitoring, treatment evaluation and course management of OSA are still in a relatively early stage, and most participants are still polishing products and exploring models. Why is this difference? How much room for imagination exists in this field? The arterial network combed through this.

Has a large patient base,

Why is the domestic OSA market not as big as imagined

According to the report "Obstructive Sleep Apnea and the Burden on the Global Economy" released by the internationally renowned medical academic journal "Lancet Respiratory Medicine" in 2019, OSA has affected the health of more than 1 billion people worldwide. Among adults aged 30 to 69 years, 936 million were mild to moderate patients and 425 million were moderately severe. Among them, the number of people affected by OSA in the mainland ranks first in the world, reaching 176 million.

According to the "Guidelines for the Multidisciplinary Diagnosis and Treatment of Obstructive Sleep Apnea in Adults", the prevalence of OSA is 2%-4%, which causes intermittent hypoxia, hypercapnia and sleep structure disorders, and can lead to multi-organ multisystem damage such as hypertension, coronary heart disease, arrhythmia, cerebrovascular disease, cognitive dysfunction, and type 2 diabetes. It can be seen that OSA is a veritable systemic disease that will cause extensive and serious health damage, and the whole society should pay attention to it.

Behind such staggering numbers, most people still don't know the true face of OSA

Low awareness rate, low early diagnosis rate and low standardized treatment rate are the current situation of OSA diagnosis and treatment in mainland China. Studies have shown that the early diagnosis rate of OSA is less than 1%, the vast majority of people do not know that they have the disease, and many people who have been diagnosed with OSA have failed to adhere to standardized and continuous treatment.

OSA is not only a common chronic disease in adults, but children are also highly ill people with OSA. The 2012 American Academy of Pediatrics guidelines stated that the prevalence of OSA in children was 4.8%. Children's OSA is the most harmful disease in children's sleep breathing disorders, if not diagnosed in time and effective intervention, it will greatly affect the growth of children, resulting in abnormal temporal development, behavioral abnormalities, learning disabilities, growth and development backwardness, neurocognitive damage, endocrine metabolic disorders and a series of complications. For children who are growing and developing, if OSA is not found and treated in time, it will often cause irreversible physical and mental development problems.

Wang Wenjing, director of Orange Family Strategy, said in an interview that OSA has not yet entered the popularization stage in China, and the number of clinical institutions that open sleep breath monitoring and multidisciplinary diagnosis and treatment in China is relatively small, and it is currently only carried out in large tertiary hospitals in some large and medium-sized cities. PSG polysomnography monitoring requires patients to sleep in the hospital under the supervision of medical staff for one night, the head, nose, mouth, chest and abdomen, arms, fingertips and other parts of the connection monitoring equipment, clinically this OSA screening diagnosis method is limited by privacy, comfort and the number of sleep center rooms and equipment and other aspects of the problem, it is difficult to carry out OSA screening on a large scale and efficiently.

In addition to the lack of public awareness, the slow clinical development is also one of the reasons for the limited development of the OSA market

Professor Wang Chen, an academician of the Chinese Academy of Engineering and president of the China-Japan Friendship Hospital, once divided the development of respiratory science in mainland China into three stages: tuberculosis, lung disease and pan-respiratory lung. First, the tuberculosis prevention and treatment stage based on anti-infectious tuberculosis; second, in the 1970s and early 1990s, the prevention and treatment of pneumoconiosis was the mainstay; third, after the mid-1990s, the development of respiratory and critical illness bundles became more and more prominent, entering the stage of respiratory critical illness and respiratory intervention.

The focus of each stage of development is determined based on the social environment and the urgency of the disease itself. Looking back at the development process of respiratory science in mainland China for more than 50 years, OSA is inconsistent with the development focus of the first three stages. However, with the advancement of clinical medicine, the department of respiratory science in mainland China is moving towards the development stage of respiratory chronic diseases and respiratory rehabilitation, and OSA, as an important respiratory chronic disease, is also receiving more and more attention and solutions.

The 2018 Guidelines for the Multidisciplinary Diagnosis and Treatment of Obstructive Sleep Apnea in Adults define OSA as a sleep-borne respiratory disorder with sleep snoring with apnea and daytime sleepiness as the main clinical manifestations. Prior to this, sleep apnea existed as a "syndrome" (OSAS).

The removal of the "syndrome" on the basis of OSAS is intended to emphasize that sleep apnea has been recognized as an independent disease with unique causes, pathologies, clinical manifestations, and clinical diagnostic measures, rather than a general term for a class of symptoms. Based on the precedent that high blood pressure and high blood sugar are from a syndrome to a chronic disease, this change is considered by industry insiders to be a major advance in the clinical development of OSA. In addition, with the advancement of diagnostic and therapeutic technologies and the improvement of people's health awareness, the external development conditions of OSA are also maturing.

The product line in the field of early screening of OSA is thin, and most companies have not found a mature business model

Accurate and timely diagnosis of sleep apnea is essential for effective treatment. This demand has also attracted many innovative companies to enter the market, and the focus of the business is on sleep monitoring and initial screening. However, by combing the development of these enterprises, Arterial Network found that most of the enterprises are still in the angel round and seed round stage, and the development is slow.

According to the arterial network, the well-known double venture "Orange Yi Family" located in Tianjin Binhai New Area is one of the very few enterprises that have completed the B round of financing. When the Orange Yi family was founded in 2014, it went straight into the field of OSA - from the development of portable screening equipment to the construction of the respiratory sleep monitoring algorithm platform, Orange Yi issued AI reports through the software and hardware system, forming a graphical trend analysis, intelligently assessing the effect of continuous treatment of patients, so that doctors and families can remotely guide patients to self-rehabilitation management. After realizing OSA screening, Orange Yi has expanded to the individualized customization of OSA treatment methods such as ventilators and oral appliances, and has developed a patient course follow-up management system, gradually realizing the integrated service mode of initial screening, home rehabilitation treatment and personalized follow-up of OSA.

Over the past seven years, orange family has grown into a leading high-tech enterprise with comprehensive digital sleep and respiratory health management services in China. In September 2021, the "Sleep Breathing Data Transmission Processing Software" independently developed by Orange Yi Family obtained the Medical Device Registration Certificate of the State Food and Drug Administration (NMPA), and through sleep monitoring and screening and providing digital anti-snoring oral appliances, ventilator treatment and other services, it further promoted its improvement of the existing channel network, covering more hospitals, dental clinics, physical examination centers and other terminal markets, and finally realized the closed-loop service of early diagnosis and early treatment of OSA early screening.

Device certification is a stepping stone to the market, requiring companies to provide products that truly solve pain points

In the view of Wang Jianjun, COO of Zhaoguan Technology, capital has always been very concerned about the sleep breathing disease market, because the base of the sick population in this field is very large. However, capital will also focus on whether the product has medical certification, the actual number of clinical applications of the company, and the marketability of the product.

Zhaoguan Technology's continuous blood oxygen saturation monitoring ring entered the market with Class II medical device certification, which can monitor the blood oxygen and heart rate data of patients during sleep throughout the night, and evaluate the severity of sleep apnea in the patient's home environment through indicators such as oxygen reduction index ODI, minimum blood oxygen, and duration of different blood oxygen percentages, and use it as a basis for judging whether treatment is needed, as well as the evaluation of the effect after treatment.

Wang Jianjun introduced that the approval of medical devices is a very long process, requiring the company's team to have perseverance and determination and continuous research and development investment, and even if it has been certified, the accuracy and reliability of the product need to be tested in a large number of practical clinical applications in the future, otherwise even if the certificate is obtained, if the accuracy and practicality of the product can not meet the actual clinical requirements, it will not be recognized by users and the market in the end.

When did the OSA inflection point appear?

In developed countries such as the United States and Japan, sleep apnea has been included in the management of chronic diseases, and the corresponding medical insurance policies and disease management models have undergone fundamental changes. The American Society of Sleep Medicine (AASM) was the first society in the world to provide telemedicine sleep diagnosis and treatment services. Sleep medicine in the mainland has also developed rapidly in recent years, affected by the new crown epidemic, sleep respiratory disease monitoring, especially in telemedicine, has also been highly valued and promoted.

Under the vigorous promotion of domestic sleep medicine management organizations and the majority of clinical sleep experts, in June 2021, the mainland issued the "Expert Consensus on the Clinical Practice of Telemedicine for Adult Obstructive Sleep Apnea Hypopnea Syndrome"; in February 2022, the "Expert Consensus on the Application of Clinical Norms for Adult Family Sleep Apnea Monitoring" was also successfully released. A new hospital-community-family remote management mode of diagnosis and treatment has quietly emerged.

Wang Jianjun believes that the telemedicine service platform can save medical resources for hospitals, reduce medical costs for patients, and allow patients to get full-process services such as OSA risk assessment, diagnosis, targeted treatment equipment and home medical services without leaving home. The diagnosis and treatment of OSA is gradually being clinically, simplified and family-oriented.

Wang Jianjun added that with the development of the Internet, mobile devices, artificial intelligence and wearable devices, a new model of patient-centered OSA telehotherapy is expected to be established. "This remote sleep monitoring and treatment system will become a development trend to meet the growing demand for medical treatment for patients with sleep disorders and promote the sleep health of the general public."

"OSA is an independent risk factor for cardiovascular and cerebrovascular diseases, about 50% of OSA patients have hypertension, at least 30% of hypertension patients have OSA, and the high correlation between OSA and hypertension has been recognized and concerned by most clinicians." Wang Wenjing said, "The mainland respiratory discipline has entered the development stage of respiratory chronic diseases and respiratory rehabilitation, chronic respiratory and airway diseases such as COPD, asthma, sleep apnea, etc., with obvious health hazards, large coverage of the population, serious complications and other characteristics, and hypertension, diabetes are facing more severe pressure on the prevention and control of chronic diseases at the grass-roots level." Therefore, how to use appropriate technology to quickly and easily screen OSA and transfer to sleep medicine center for treatment will be an effective means to effectively improve the awareness rate, treatment rate and standardized management rate of OSA in the future. ”

I would like to thank the Orange Family and Zhaoguan Technology for their strong support for this article.

*Cover image source: 123rf