FDA approves Advanced Brain Monitoring's Sleep Profiler to be used in the diagnosis of sleep apnea.

The 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.

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.