Aculys Pharma, Inc. (“Aculys”), a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, and Four H, Inc. (“Four H”).
A Japan- based company specializing in health technology, an exploratory research collaboration using wearable devices to help patients with narcolepsy and excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS).
In its quest to establish a new pharmaceutical model, Aculys is promoting DX (digital transformation) in clinical trials and medicine.
In this collaborative exploratory study to be launched with Four H, Aculys will collect trial participants’ subjective assessments of their sleep as well as data on their sleep, activities, and heart rate acquired from wearable devices to be worn each night during the clinical trial period.
These data will be analyzed in conjunction with other data to be obtained in the clinical trial with the goal of identifying sleep-related digital biomarkers.
This exploratory research program will be characterized by the following three points:
Objective understanding of narcolepsy, OSAS, and its characteristics (sleep condition, daytime sleepiness, etc.)
Analysis using AI and other methods to collate the subjective assessment by patients and objective assessment obtained by the wearable device
Development of appropriate and reliable digital biomarkers for future clinical trials and clinical setting
Through the above approach, which is unprecedented in conventional clinical trials for sleep-related diseases, the following outcomes are expected: objective understanding of patients' sleep status, analysis of daytime sleepiness patterns, extraction of sleep characteristics, and daytime activity data through comparison with people without symptoms, and detection of predictive signs of the onset of daytime sleepiness.
Sleep disorders are difficult to objectively identify, and largely rely on the memory and self-reporting of patients themselves, causing a range of challenges in diagnoses and appropriate treatment.
This exploratory research will allow a further accurate understanding of each patient’s sleep and lifestyle patterns, which had been difficult to measure previously. Over the long term, we collectively plan to build a comprehensive sleep ecosystem for patients, including: digital biomarkers which can be used to predict health risks; personalized data to improve patient quality of life and productivity; and quality disease management programs that patients can utilize at home.
About Sleep Disorders* in Japan:
The impact of sleep-related disorders on Japanese society is enormous. Research shows that presenteeism (decreased productivity at work due to health issues) and absenteeism (absence or sick leave due to health issues) is causing an economic loss of about 3% of Japanese GDP, equivalent to about 15 trillion yen1. Japanese people also sleep less than people in other countries due to lack of understanding about the importance of sleep. The Japanese government’s “National Health Promotion Movement in the Twenty-First Century (Health Japan 21)” includes sleep as one of the key themes in attempting to raise awareness2-3.
Sleep disorders are also factors that interfere with proper sleep and daytime sleepiness. It has been reported that delays in appropriate medical intervention for sleep disorders and complications associated with sleep disorders (e.g., cardiovascular diseases, depression) increase overall costs to society including medical care expenditure4-7. In order to improve the patient’s quality of life, prognosis, productivity, and other factors, it is necessary to detect sleep disorders accurately and provide appropriate medical care at an early stage.
*General term for sleep-related illnesses, including insomnia, sleep-related breathing disorders (e.g., OSAS), and central hypersomnia (e.g., narcolepsy)
About Four H, Inc.:
Health infrastructure is a must-have in order to maintain the healthy lives of people so that they can fulfill active lives in pursuit of happiness. Our mission is to foster the health industry that supports good health. By building an infrastructure for people to stay healthy, and by working together with medical institutions, pharmaceutical companies, medical device manufacturers, and health-related companies, we aim to create a society where people can strive to maintain good health, even before they become ill.