The long-term goal of this SBIR is to develop an improved full PSG / CPAP titration device for the home and the lab. Despite numerous improvements in data manipulation and analysis, the patient interface responsible for the critical role of generating the inputs has received little attention and remains unoptimal. Current PSG and CPAP titration patient interfaces use sensors and conventional electrode assemblies that are too busy, cumbersome to wear and generate indirect or noisy data. The proposed device will improve signal sensitivity, patient comfort and reliability by developing a new dedicated patient interface. The proposed device will incorporate three innovative features: I) miniaturized 23 channel headwom amplifier system for EEG/EOG, 2) non-contacting upper airway microsensors that plug in-line with the air hose proximal to the mask, and 3) a small recorder unit with novel micro data storage medium and wireless data transmission capability. BIOMEC will capitalize on technologies being developed for other applications. Although the primary targeted market is the lab, in-home studies will also benefit from such a device. Compactness and wearability will make the proposed device the first in-home sleep disorders monitor with in-lab capabilities. In Phase I, we tested the feasibility of embedded microsensors, miniaturized wearable hardware and micro data storage. In Phase II, we will complete the hardware design by integrating all the components together, and conduct clinical studies on 12 patients. The final product promises to set the standard for a new class of full PSG and CPAP titration for the lab and home.
The proposed device will have the capability of in-lab PSG devices but with the mobility and ease of use of home devices. The commercial potential include lab and home screening and monitoring of sleep disorders such as OSA, and isomnia. The total number of sleep labs is expected to exceed 2500 in the US alone. The total market for sleep diagnostic products is estimated at $104 million and is growing at 8% annually. One of the biggest drivers is the untapped OSA population, which is estimated at over 11 million. there is a huge need for improved diagnostic devices that generate sensitive recordings in a more comfortable patient interface. Also, a more compact and reliable patient interface will permit home use, which is one of the high growth market segments due to lower cost and more convenient procedure setting.
