Advanced Medical Electronics Corporation (AME) proposes to develop a wearable sleep diagnostic device that allows frequent signal quality checks through an embedded cellular telephone wireless Internet connection. This proposed system will improve access to sleep testing by increasing the reliability of out-of-lab testing which will reduce overall testing costs. A patient identified for a home sleep study will receive the device through overnight delivery service. Clear instructions will guide the patient in the placement of respiratory cannula (air flow and snore), a finger pulse oximetry sensor, and two effort bands. The patient and a monitoring technician can audibly communicate through the proposed device to assist in setup and make sensor corrections if needed during the night. Thirty-second epochs of recorded data will be sent periodically through the wireless Internet connection embedded in the device. Technicians will manually or automatically monitor data collection using an Internet connection to verify signal quality. The device is returned through overnight delivery. Study costs will be significantly reduced due to the increased reliability of data collection. Phase I will show the feasibility of combining a sleep diagnostic device with an embedded cellular Internet interface. Phase II will develop prototypes and implement a trial program.
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