Sleep App Gets Clinical Trial Go-Ahead
Helsinki Committee approves the trial of SleepX Pro, a home sleep apnea testing app for smartphones.
Israel-based SleepX, a subsidiary of AppYea that develops wearable monitoring solutions to treat sleep apnea, has received approval from the Helsinki Committee to begin a clinical trial on its SleepX PRO application.
The Helsinki Committee authorizes clinical trials in Israel. The SleepX Pro trial is the first step toward applying for an FDA approval under the first-of-its-kind medical device category for contactless detection of sleep apnea to be performed via artificial intelligence (AI) analysis of breathing during sleep.
SleepX Pro is designed to diagnose sleep apnea using only a smartphone and requires no physical contact with the subject.
“Poor sleep is associated with the compromised immune system, heart problems, reduced physical and mental performance, mood problems, obesity, and many other health problems,” said Neil Kline, founder and former CEO of the American Sleep Association and an AppYea Board Member. “Unfortunately, most people with sleep disorder breathing problems, like sleep apnea, are undiagnosed and untreated. Our goal in this unique technology is to raise the awareness of the problem and to improve people’s they can live healthier and more fulfilling lives.”
“SleepX PRO makes for a unique, quick and friendly diagnosis tool that will prevent subjects from having to spend nights at sleep labs while saving the healthcare system and insurance companies hundreds of millions of dollars,” said Boris (Bary) Molchadsky, President and CEO of SleepX, and Chair at AppYea. “We plan to make our diagnosis solution highly accessible, so people get tested easily.”