Obstructive Sleep Apnea (OSA) affects 12 million people. It is caused by frequent closure of the upper respiratory airway obstructing breathing during the night. Nasal Continuous Positive Airway Pressure (N-CPAP) is the most effective OSA treatment; it opens the airways by creating positive pressure in a nasal mask. Although treatment is efficacious and relatively straight-forward the diagnostic study to prescribe it (CPAP titration) remains inconvenient and costly. CPAP titration studies are conducted overnight in the hospital, which is expensive. Hospitals are also overcrowded, and the unfamiliar setting causes many patients to lose sleep thus preventing accurate pressure titration. This approach discourages enlisting, and is partly responsible for the disproportionately low numbers of OSA patients who are treated (1 million out of the estimated 12 million). The home is a more natural setting and holds great potential in addressing the existing patient demand. It is more convenient and cost effective but current ambulatory devices are unsuited for in-home CPAP titration. They rely on traditional patient interfaces that are unreliable and generate signal quality that is often compromized by patient movement. This discourages patients from using and physicians from prescribing in-home studies. Phase I will demonstrate feasibility of a novel patient interface that utilizes miniaturized wireless pressure and airflow sensors embedded in the mask, and wireless transmission of biopotential data (EEG, EKG,.) with a compact Bio-amplifier. We will construct a prototype of the proposed interface and compare it with conventional approaches. Phase II will develop the commercial patient interface and a recording unit with modem capability for on-line remote monitoring between the home and the clinic.
There is a huge potential market for this device. Out of the estimated 12 million people who suffer from OSA only 1 million patients are treated leaving a huge demand that is unmet. The proposed device will expand treatment by allowing patients to be diagnosed at home; thus help raise total sales of respiratory products such as masks, monitors, .. etc. The sleep apnea products segment of the respiratory devices market posted revenues of $122 million in 1996. The commercial potential for the proposed device is not only for home use but the new patient interface can also benefit traditional in-lab studies because it improves patient mobility without compromising data integrity.
