LifeShirts get OK from FDA
by Lenny Roberts

What we wear may soon prove as medically important as what we say or do.
Instead of spending hours in a doctor's office or hospital to determine what's going on inside their bodies, people at risk or suffering from potentially life-threatening illnesses can now be monitored as they go about their daily business.
Described as futuristic clothing that monitors its wearer's health, the garment that tracks health while people work, play and sleep has just been given a clearance by the Federal Food and Drug Administration.
"VivoMetrics expects the LifeShirt System to have a huge impact on the way that research is conducted and medicine is practiced, across many health care categories," according to Jeff Speer of Los Angeles-based Fischer Health.
The LifeShirt is a washable garment manufactured by San Jose-based StellarTech that collects and records a wide range of physiologic parameters while wearers go about their normal daily routine. Stored on a handheld computer and uploaded to a Web site by the LifeShirt wearer, the data is then analyzed by a doctor on his or her desktop computer. Medical researchers and clinicians and the military have been investigating the applications of the system.
Ojai resident, Living Treasures founder and LifeShirt board member Sanford Drucker, who suffered a heart attack in 1991, wore the original prototype shirt with sensors to record his basic heart rate, oxygen levels and blood pressure measurements plus 37 additional critical body functions over each 24-hour period.
As reported in the OVN in December 1999, the LifeShirt System was invented by Dr. Marvin Sackner, a professor of medicine at the University of Miami at Mount Sinai. Sackner is the son-in-law of Ojai resident Andy Behar, co-founder of VivoMetrics.
Also an Ojai resident, VivoMetrics president Paul Kennedy earned a degree in economics at the University of London, and pursued a career in e-commerce software development, eventually becoming president and chief executive officer of Metromedia before heading up LifeShirts.com, the company's original name.
But Speer, who handles public relations for VivoMetrics, explained that the LifeShirt can be of great value for lesser-known but still dangerous conditions
"One of the LifeShirt System's first applications will be in the at-home diagnosis of sleep disorders - a high-profile topic in the recent press, and of keen interest to the more than 40 million Americans whose poor-quality sleep puts them at risk for hypertension, heart disease and even death," Speer explained.
"In addition to its use in sleep diagnostics, the LifeShirt System will help drug and medical device companies monitor patients remotely during clinical trials. It will also be a powerful new tool for studying the causes and prevention of a host of respiratory, cardiovascular, behavioral and sleep-related diseases and disorders."
Typically, the cost for monitoring an individual with sleeping disorders overnight can run between $800 and $2,000, according to LifeShirt president and CEO Paul Kennedy. Monitoring a patient with the LifeShirt System costs around $500.
Kennedy said there have been a couple of thousand LifeShirts manufactured so far, with approximately 200 being used mostly in research at institutions throughout the United States, including Stanford University, Penn State and Columbia University, and Europe.
"With the FDA clearance, the next step is at-home diagnosis of sleep disorders. We can classify sleep disorders now, and we 'll be fully operational by end of this month," Kennedy said. LifeShirts, however, will not be marketed directly to consumers, but will be available as a prescription device.
Steve Knapp of Ojai was referred to LifeShirt Systems by the Landon Pediatric Group in Ventura. Kennedy explained that Knapp, along with millions of other Americans, have sleep-related disorders who until now, must sleep in a lab and be monitored by a technician. Not only is it expensive and inconvenient, but inaccurate as well.
"We can do this now for a person in the comfort of their own home," Kennedy said, adding that there was a sleep study performed on Knapp and the diagnosis confirmed that he was indeed suffering from obstructive sleep apnea, a condition where the subject wakes up 30 to 40 times a night with never a decent night's sleep.
Knapp said personal friend Dr. Chris Landon had been doing research for VivoMetrics, and the Landon Pediatric Group was a corporate sponsor for a 10K run the Knapp and his wife, Kathy, promote each year in memory of their son, Dan, who died in the late 1990s of cystic fibrosis.
"We had a bunch of LifeShirts for runners to wear at the event, but I do the barbecue, so I didn't put one on," Knapp recalled. "My wife had told me for a long time that I snore at night and stopped breathing. Chris told me to put one on and see what happened."
Within a month, a call came from VivoMetrics.
"They wanted to take one home for a study," Knapp said. "I went home, went to sleep, took it off in the morning and took the little PDA (data recorder) back to their office," and Knapp was diagnosed with moderate to severe sleep apnea.
At the suggestion of Landon, Knapp then went to a sleep clinic for a one-night evaluation to reconfirm the findings. The results were the same, including verification of his many wake-ups and even one 46-second lapse in breathing. Knapp was issued, and insurance paid for, a C-PAP breathing device that forces oxygen into a patient's airway while he or she sleeps.
"I don't snore anymore, and now I have vivid dreams because I get into deep R.E.M. sleep. My wife says that it's eerie because there's no noise in the house at night. She's sleeping a lot more comfortably," Knapp said.
Knapp's oxygen saturation level during sleep, which hovered around an extremely low 76, now typically is in the 96 to 98 range - the same as it is when he is awake.
Knapp turns 54 this week and runs the transportation department at Pictsweet Mushroom farm in Ventura. He has learned from doctors that uncorrected sleep apnea can be a major contributor to early senility.
"I think the LifeShirt is a great product, something that will make the initial diagnosis of sleep apnea a whole lot easier for a whole lot of people," he said.
Beginning next month, LifeShirts will be used on people in clinical drug trials where better data is a critical asset. Kennedy said of every five drugs that get tried out on humans, only one makes it, and "the quicker you can find out which ones make it, the better it is for everybody."
For more information on LifeShirts, visit lifeshirt.com.

© 2002 The Ojai Valley News

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