The US Food and Drug Administration (FDA) has cleared Sunrise’s second-generation home sleep test, which uses a novel way to measure sleep—through the biosignal of mandibular jaw movements. The device, which uses artificial intelligence to aid in the diagnosis of obstructive sleep apnea and other sleep-related breathing disorders, uses mandibular jaw movements signal alongside the traditional signals of airflow and oximetry.
“We have clinically validated our sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing,” says Laurent Martinot, Sunrise CEO and co-founder, in a press release.
Atul Malhotra, MD, board-certified pulmonologist, intensivist, and research chief of pulmonary, critical care, and sleep medicine at UC San Diego Health, says in a press release, “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”.
New features that will be available on Sunrise’s home sleep apnea test include the ability for patients to complete multi-night testing. “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,” Malhotra says.
Sunrise’s technology captures mandibular jaw movements with one point of contact, a sensor placed on the chin. Sunrise home sleep test data is collected through an app, analyzed with an algorithm using artificial intelligence, and made available to healthcare providers through a secured online portal.