The US Food and Drug Administration (FDA) has granted 510(k) clearance for Sleep Profiler, a patient-friendly neuro-cardio diagnostic tool to assess sleep architecture and continuity, developed by Advanced Brain Monitoring.
“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 Dr Philip Westbrook, chief medical officer, Advanced Brain Monitoring. “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 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 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.”