Sam Brusco, Associate Editor02.14.23
Belgian firm Sunrise has received U.S. Food and Drug Administration (FDA) clearance for its second-gen at-home sleep apnea test, which uses artificial intelligence (AI) to aid in diagnosing obstructive sleep apnea and sleep-related breathing disorders.
The company is using a new way to measure sleep via the bio-signal of mandibular jaw movements (MJM), which has been studied for decades.
Laurent Martinot, CEO and co-founder of the company, said the new device utilizing the powerful MJM signal alongside traditional signals of airflow and oximetry brings a new level of clinical information and ease of use.
“We have clinically validated our sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing,” he told the press.
To use the test, a lightweight sensor is placed on the chin that records jaw movements. Data is collected through an app, then analyzed with an AI algorithm and made available for clinicians via a secured, online portal.
Atul Malhotra, MD, board-certified pulmonologist, intensivist and research chief of Pulmonary, Critical Care and Sleep Medicine at UC San Diego Health, added, “Home sleep tests have come a long way in recent years and are now well established in diagnosing sleep disorders in appropriate patients. Despite this success there remain shortcomings and the Sunrise device appears to close some of these gaps in its ability to convey relevant information about hypoxic burden and total sleep time spent with increased respiratory effort, a key component of obstructive sleep apnea that has been linked to cardiovascular and mortality outcomes".
Patients can also complete multi-night testing on the at-home sleep apnea test.
“Night to night variability in sleep studies is well documented and incorporating a multi-night capability in an economical manner, allowing to capture longitudinal data over time, will improve diagnostic confidence,” explained Malhotra.
The company is using a new way to measure sleep via the bio-signal of mandibular jaw movements (MJM), which has been studied for decades.
Laurent Martinot, CEO and co-founder of the company, said the new device utilizing the powerful MJM signal alongside traditional signals of airflow and oximetry brings a new level of clinical information and ease of use.
“We have clinically validated our sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing,” he told the press.
To use the test, a lightweight sensor is placed on the chin that records jaw movements. Data is collected through an app, then analyzed with an AI algorithm and made available for clinicians via a secured, online portal.
Atul Malhotra, MD, board-certified pulmonologist, intensivist and research chief of Pulmonary, Critical Care and Sleep Medicine at UC San Diego Health, added, “Home sleep tests have come a long way in recent years and are now well established in diagnosing sleep disorders in appropriate patients. Despite this success there remain shortcomings and the Sunrise device appears to close some of these gaps in its ability to convey relevant information about hypoxic burden and total sleep time spent with increased respiratory effort, a key component of obstructive sleep apnea that has been linked to cardiovascular and mortality outcomes".
Patients can also complete multi-night testing on the at-home sleep apnea test.
“Night to night variability in sleep studies is well documented and incorporating a multi-night capability in an economical manner, allowing to capture longitudinal data over time, will improve diagnostic confidence,” explained Malhotra.