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
"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
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
"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
"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
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
"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
Back to the news