Intelligent Quantitative CPAP for OSA therapy
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, 44103
AbstractDESCRIPTION (provided by applicant): The long term objective is to develop a new class of Continuous Positive Airway Pressure (CPAP) devices that in addition to treating OSA patients can simultaneously record EKG, pulse oximetry, respiration and airflow for accurate therapy assessment. CPAP is by far the most common therapy for patients with Obstructive Sleep Apnea (OSA) with over 300,000 new therapies initiated each year. Unfortunately, once prescribed, CPAP treatment is not typically monitored. In order to properly assess symptoms, patients must be brought back to the lab for evaluation, which is expensive, inconvenient and has long waiting periods. Some of the more advanced CPAP machines can monitor patient's airflow pattern during the night. However, accurate patient follow up requires additional cardiorespiratory information to clearly evaluate Apnea Hypopnea Index and cardiac function, which are prime therapy objectives. This is especially true for OSA patients with co-morbid diseases such as CHF and COPD whose hemodynamic response is affected by CPAP. Also, detailed therapy efficacy data speeds intervention and generates encouraging feedback to the patient, which has been shown to improve CPAP compliance. We propose to develop a new CPAP device that can accurately and conveniently monitor treatment progress with measurements of EKG, chest effort, pulse oximetry and airflow. When monitoring is needed, patients simply wear two small and separate wireless sensors under their clothing, which transmit data to the CPAP machine that is equipped with special data reception, storage capability and analysis algorithms. The CPAP downloads the data to the doctor's office where raw waveforms and quantitative information such as AHI and heart rate variability are provided. Each sensor can be easily reused and can last up to 6 nights without battery replacement. The ultimate success of the proposed device will depend on the sensors being very small, accurate and easy to apply without instruction, in Phase I, we will develop the software and hardware for prototypes of the wireless sensor components and test on 5 subjects to ensure signal fidelity and ease of use. Phase II, will complete sensor development, develop the CPAP and conduct clinical testing.
* information listed above is at the time of submission.