At-home sleep apnea screening.

The FDA has approved Influ-ENT's SleepStrip [TM], a disposable low-cost screening device for adult patients who snore or are suspected to have sleep apnea. This single-use, at-home screening device monitors respiration, using oral and nasal thermistors and real-time analysis hardware and software. Following a night of at least 5 hours of recording, a score is displayed on a built-in data screen, which represents the number of apnea and hypopnea occurrences per hour of recording. SleepStrip is meant to serve as a prediagnostic tool, to help determine which patients should receive immediate and more in-depth testing.

The patient places the 15-cm plastic strip over his/her upper lip before going to sleep. Three tiny temperature sensors on the strip report every incident of cessation of breathing to a tiny processor, also located on the strip. In the morning the patient removes the sticker and submits the device to his or her doctor, who can immediately read the test results on a built-in, permanent display. A tiny battery integrated in the strip supplies power to the sensors and the processor.

To evaluate the reliability of SleepStrip against the Respiratory Disturbance Index (RDI) obtained by traditional polysomnographic recordings, three studies were conducted independently in Belgium, Germany and Israel. Seven additional studies are under way in North America, including 350 study patients. Based on 402 completed patient studies, SleepStrip appears to be highly correlated to lab PSG. In lab value RDIs greater than 30, SleepStrip correlates at approximately 99%; in lab value RDIs less than 20, it exhibits a sensitivity of 81%.