New study finds remote sleep testing 96% accurate

Monday, December 31, 2001

Research that quantifies the cost effectiveness of home-based sleep monitoring has resulted in some favorable attention for Palo Alto, Calif.-based Sleep Solutions, a development that company officials are hoping will propel remote apnea testing into the mainstream.

In recognizing Sleep Solutions' recent clinical study that compares its home sleep monitoring system to a sleep lab polysomnogram, San Jose, Calif.-based research firm Frost & Sullivan named the company as the winner of its 2001 Market Engineering Entrepreneurial Company Award.

Recipients are selected for "demonstrating superior entrepreneurial ability in (their) industry," a Frost & Sullivan release stated. The Sleep Solutions study, conducted at the University of California-San Francisco/Mount Zion Sleep Disorder Center, identified "a unique and revolutionary product solution with significant market potential" and that the three-year-old company's "marketing strategy is sound and poised for success," Frost & Sullivan declared.

The award isn't just an honor, it's a confirmation that the home sleep monitoring system legitimately belongs in the world of sleep medicine, says Sleep Solutions CEO Dan Dugan.

The most prominent finding in the study, titled "Clinical Validation of the Bedbugg in Detection of Obstructive Sleep Apnea" and published in a recent issue of the Journal of Otolaryngology-Head and Neck Surgery, is a 96% correlation in accuracy rates between the Sleep Solutions Bedbugg monitor and a PSG conducted in a laboratory setting.

"The Bedbugg System is a prospectively validated technology proven to be clinically accurate," said David Claman, MD, director of the UCSF Sleep Disorders Center and lead investigator. "This has potential to provide access to quality diagnoses for a higher proportion of undiagnosed sleep apnea patients."

This doesn't mean the sleep lab will become obsolete, however, company officials insist. Their justification of home monitoring rests on the assertion that it is the most effective way to detect apnea among the 18 million nationwide estimated to have sleep disorders.

"Finding those individuals requires testing twice that many," Dugan explained. "So we have to test 35 million or 40 million to find those afflicted. There are between 2,000 and 2,200 sleep labs across the country, and they probably have a maximum capacity of about one million a year."

Bruce Ardornato, MD, medical director for Sleep Solutions, calls the situation "a 50-year backlog."

By having the ability to screen a large volume of people, home monitoring is a viable alternative in sleep therapy, Dugan and Ardornato said.

"We don't see ourselves as competitors to the sleep lab - we are an extension of it," Dugan said.

By verifying the home-based system's accuracy, Sleep Solutions and other respiratory manufacturers like Pittsburgh-based Respironics (which makes a similar unit called Stardust) can present this data to sleep physicians in hopes they will embrace the home monitoring concept. In a cost-conscious environment, home-based testing should be attractive to them, Dugan said.

"Our hope and belief is that we will ultimately collaborate with the sleep society because they stand to gain the most from technology like ours," he said. "The sleep lab process is not efficient - they have a heavy labor component and their diagnostic systems are more expensive to use and maintain. Our numbers show that we are 50% to 75% less expensive."

Even so, the sleep medicine establishment may need more convincing. Jerry Barrett, executive director of the Rochester, Minnesota-based American Academy of Sleep Medicine, says clearer cost distinctions need to be made.

"I don't know if the cost issue is as clear as they'd like you to believe it is," he said. "It takes just as much time to read and analyze their results as it does for lab-based tests. And a sleep lab can diagnose apnea in just a couple hours and begin treatment immediately."

But is apnea screening the most efficient use of the sleep lab? With accurate home apnea testing available, Ardornato asserts that labs would be free to concentrate on more complex sleep disorders like somnambulism and narcolepsy.

"There will always be sleep labs and a need for them," he said. "Their use of sleep scoring and EEG monitoring is beneficial for treating patients with serious sleep behaviors." HME