The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Advanced Brain Monitoring’s Sleep Profiler to be used in the diagnosis of sleep apnea. Sleep Profiler is a self-applied system for the assessment of overnight EEG that has historically been used in patients with insomnia or mood disorders. With this clearance, The Sleep Profiler PSG2 can now also be used with patients suspected to have obstructive sleep apnea.
“Sleep Profiler PSG2 meets the requirements for unattended polysomnography, the most accurate method for in-home assessment of sleep-disordered breathing,” says Philip R. Westbrook, MD, chief medical officer of Advanced Brain Monitoring and past?president of the American Academy of Sleep Medicine, in a release. “Clinical study results, required for FDA clearance, showed the Sleep Profiler PSG2 delivers unparalleled accuracy in the automated detection of sleep stage-dependent mild and moderate sleep apnea.”
The Sleep Profiler provides clinicians a powerful new tool to objectively evaluate sleep patterns that are proven contributors to disability, morbidity, and mortality. Clinicians can now obtain a home sleep test that assesses rapid eye movement (REM)-related obstructive sleep apnea, a condition associated with hypertension and depressive symptoms. A Sleep Profiler PSG2 study result can identify patients with abnormal sleep duration and efficiency, decreased slow wave sleep, and increased cortical arousals—factors which have been associated with increased hypertension, obesity, diabetes, and memory impairment. An overnight EEG assessment with Sleep Profiler allows clinicians to differentiate sleep state misperception from insomnia and circadian rhythm sleep disorders.
“Sleep Profiler includes automated sleep staging,” says Daniel J. Levendowski, president and principal investigator of the study. “Results showed the Sleep Profiler accuracy in detection of REM sleep and slow wave sleep was equivalent to manual scorers from different sleep laboratories.”
Is there any way to do home testing and establish chain of custody of the device, especially if it is mailed to the patient rather than set up in person. Thanks.