Sleep Profiler PSG2 Cleared by FDA to Diagnose Sleep Apnea

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Advanced Brain Monitoring Inc.’s Sleep Profiler, a self-applied system for the assessment of overnight EEG in patients with insomnia or mood disorders, to be used in the diagnosis of sleep apnea.

“Sleep Profiler PSG2 meets the requirements for unattended polysomnography, the most accurate method for in-home assessment of sleep-disordered breathing,” said Dr. Philip R. Westbrook, chief medical officer of Advanced Brain Monitoring and past president of the American Academy of Sleep Medicine. “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 which 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,” said 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.”

According to the American Academy of Sleep Medicine, 23.5 million adults in the United States have undiagnosed obstructive sleep apnea, which has an estimated annual cost of $199 billion, based on increased healthcare costs, lost productivity, motor vehicle and workplace accidents. An additional 25 percent to 30 percent of the adult population suffers from insomnia and mood disorders resulting from poor sleep quality. Insomnia has been estimated to contribute to 24 percent of all workplace accident costs, resulting in a $31 billion per year loss to employers.

Advanced Brain Monitoring, headquartered in Carlsbad, Calif., is a privately held developer of technologies to diagnosis and treat sleep, neurological, and psychiatric disorders. The company has been issued 20 patents for its diagnostic and therapy products, which have been used on over 350,000 patients worldwide.