FDA clears Sleep Profiler for neuro-cardio assessment of sleep quality


The US Food and Drug Administration (FDA) has granted 510(k) clearance to Advanced Brain Monitoring for its Sleep Profiler, a patient-friendly neuro-cardio diagnostic tool to assess sleep architecture and continuity. 

According to the National Institutes of Health, an estimated 25-30% of the general adult population suffers from compromises in sleep quality which are proven contributors to disability, morbidity and mortality. “Research has shown that sleep patterns can help differentiate depression from other causes of insomnia and provide biomarkers for early detection of diabetes and hypertension,” said Philip Westbrook, chief medical officer, Advanced Brain Monitoring, and past-president, American Academy of Sleep Medicine. “Sleep Profiler provides clinicians a powerful new tool to objectively assess the impact of sleep quality management on chronic diseases, and differentiate sleep state misperception from insomnia and circadian rhythm sleep disorders.”

“Sleep Profiler includes automated sleep staging, an important feature validated in a recent peer-reviewed study,” said Daniel J. Levendowski, president and principal investigator of the study. “Results showed the Sleep Profiler accuracy in detection of slow-wave-sleep (SWS) and rapid-eye-movement (REM) sleep was the same as manual scorers from different sleep laboratories.” Sleep Profiler measures sleep duration and sleep efficiency, patterns and density of SWS and REM, cortical, sympathetic and behavior arousals, and frequency and intensity of snoring. “Sleep Profiler metrics can assist researchers achieve the five goals of the 2011 NIH Sleep Disorders Research Plan,” said Westbrook.