FDA approves at-home sleep apnea testing device created by a KITE scientist

Innovative device from Bresotec Medical will increase accessibility by allowing people to conduct sleep apnea tests in the comfort of their own homes

Bresotec Medical, a company co-founded by Dr. Douglas Bradley, KITE Senior Scientist and Director of the Sleep Research Laboratory at Toronto Rehab, has received clearance from the United States Food and Drug Administration (FDA) for BresoDX1 — an at-home sleep apnea diagnostic testing device.

“We were delighted to learn the FDA had passed our device for clinical use in the United States,” said Dr. Bradley, who is Bresotec Medical’s chief medical officer. “It’s a major milestone and it’s the first step to commercial success for us.” 

Sleep apnea is a condition characterized by recurrent cessations of breathing during sleep. This leads to interrupted sleep, excessive daytime sleepiness and increased risk of hypertension, heart failure and stroke. Typically, those who suspect they may have this condition are required to stay overnight in a laboratory for a sleep apnea test. 

“For many people this test is inaccessible due to the lack of sleep laboratories in their area, the high costs associated with the test, or the inconvenience of having to spend a night in an unfamiliar setting. As a result only 15 per cent of people with sleep apnea are diagnosed and treated,” said Dr. Bradley, who is also a professor of medicine and former director of the Division of Respirology at the University of Toronto.

“BresoDX1 is an easy–to-use device that will allow patients to conduct a sleep apnea test in the comfort of their own home. This will increase accessibility for sleep apnea testing for all, but particularly those in rural communities.”

To use BresoDX1, patients place a sensor on their neck over the trachea (windpipe) and wear an oxygen sensor on their finger. Combined, these inputs record the patient’s tracheal breathing sounds and movements, neck and body position, oxygen saturation, and heart rate during sleep. 

This information is uploaded wirelessly to a secure network for preprocessing and storage. It is then analyzed by the BresoDX1 software, which generates a comprehensive sleep report that can be reviewed by a patient’s physician.  

Bresostec Medical is a start-up company spun-off from KITE at Toronto Rehab, and Toronto Innovation Acceleration Partners (formerly known as MaRS Innovation) –a not-for-profit organization that specializes in  venture building of early-stage health science technologies.

BresoDX1 was tested at KITE’s Sleep Research Laboratory and is another example of the institute’s ability to foster start-up companies and to assist industry partners in achieving goals compatible with KITE’s research objectives. 

“KITE and Toronto Rehab have been really supportive,” said Dr. Bradley. “We could not have achieved this without their support.”