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The Pipeline

Rich pipeline of portable sleep monitoring devices adds hope for improved diagnostics

Up to 64% of Americans suffer from sleep-related disorders, such as obstructive sleep apnea, daytime sleepiness, and insomnia. Despite high prevalence of sleep disorders, where the top sleep problems afflict 50 million people, the diagnosis of sleep disorders remains severely underpenetrated. According to the National Sleep Foundation, an estimated 3 million people receive a diagnostic test for sleep disorders in 2009, which is only a fraction of the total patient population that could benefit from such a test. Many patients are unaware that they suffer from a sleep disorder that diminishes their productivity, while others do not want to spend a night in a hospital's sleep laboratory for diagnosis as it is uncomfortable and foreign to them.

In this environment, interest around portable sleep monitoring has increased. Portable sleep monitoring systems are designed to be used in lieu of in-lab polysomnography tests for the diagnosis of obstructive sleep apnea and other disorders.

This week, Advanced Brain Monitoring announced that it will submit a 510(k) application for its Sleep Profiler portable sleep monitoring system. Worn on the patient's forehead, Sleep Profiler uses electroencephalography (EEG) sensors to measure the brain's electrical activity and actigraphy technology to measure sleep stages while the patient sleeps at home. The system also includes a microphone and pulse rate sensor to measure snoring, heart rate, and other physiological activity. The data collected can be accessed on computers and used to diagnose and direct treatment for daytime sleepiness, insomnia, and depression.

Sleep Profiler goes beyond current portable sleep monitoring devices in that it can be used to diagnose sleep conditions other than obstructive sleep apnea. Once it gains 510(k) approval, Sleep Profiler will complement Advanced Brain Monitoring's other portable sleep test, ARES, which is used for the diagnosis of obstructive sleep apnea. Meanwhile, other products in the company's pipeline include Apnea Guard, a mouth guard intended to treat sleep apnea and snoring, and Night Shift, a neck band that prevents patients from sleeping on their backs and exacerbating sleep apnea symptoms.

With a market for portable sleep monitors developing and vendors introducing several products, focus now is on the clinical efficacy of portable monitors over in-lab tests. Also, reimbursement for these devices still needs to be determined. Sleep Profiler, for example, costs between $3,000 and $7,000, and securing both Medicare and private reimbursement for these tests will be key for physicians (and patients) to adopt it.