Blood Pressure System to Diagnose Brief Arousals

Period of Performance: 05/01/1998 - 10/31/1998


Phase 1 SBIR

Recipient Firm

Innerspace Medical, Inc.
Irvine, CA 92705
Principal Investigator


Over three percent of the population suffer from sleep problems severe enough to affect health and daily function. There is a growing sentiment that the severe physiological consequences of sleep problems are related to the number and severity of brief arousals that occur as a result of obstructive sleep apnea, elevated upper airway resistance and/or leg motion. Blood pressure is one of the most definitive markers of brief arousal and the only noninvasive means to detect upper airway resistance, yet it is not routinely used in sleep studies since currently available noninvasive systems arouse the patient while measuring BP. The company proposes to develop and test a novel system that measures BP by means of a forehead sensor. If successful, it will make possible routine measurement of BP in either the sleep lab or a home based study. In Phase I, the company will modify and existing forehead-based BP system and evaluate its ability to define brief arousals by monitoring short-lived BP excursions on a beat-to-beat basis. The study will be conducted in a recognized sleep laboratory. PROPOSE COMMERCIAL APPLICATION Over 250 laboratories conduct sleep studies involving over 150,000 patients in the U.S. A similar number of patients are screened internationally. Economic pressures are moving screening from the sleep lab to the home setting. A functional product would provide improved analysis in the sleep lab and simplified economical monitoring in the home. The market for instruments and single-use forehead sensors is estimated to exceed 5 million dollars per year.