0634 A Novel Approach for OSA Treatment in CPAP-Intolerant Patients

Abstract Introduction CPAP is the first-line treatment for OSA, although adherence is universally low with estimates at ~50%. Current alternatives to CPAP involve complex, highly invasive surgical procedures (e.g. maxillomandibular advancement surgery) as well as implantable medical devices for delivering hypoglossal nerve stimulation. This affirms an urgent need for an acceptable alternative to CPAP therapy. We have developed a nasopharyngeal/oropharyngeal airway device (“NPOP”), a flexible, medical-grade silicone, open channel tube-like device that is self-inserted into the nasopharyngeal airway through one nostril. It is held in place via an integrated nose clip. We present initial findings of the NPOP device. Methods This pilot feasibility study recruited patients with moderate-to-severe obstructive sleep apnea who did not tolerate CPAP to test the device and provide feedback about insertion and comfort. Each participant underwent overnight polysomnography before using the device and again after one month of use. Polysomnographic measures were compared using paired t-tests. Results Thus far four male participants have completed the trial. Mean age was 62±9.1 years and mean apnea hypopnea index (AHI) was 43.8±21.7. All four found the NPOP moderately easy/very easy to insert. Two were able to sleep all night with the device in place from the first night while the other two were able to sleep with the device within five nights. After one month of use repeat polysomnography demonstrated a slight reduction in overall AHI (43.8±21.7 to 32.7±17.6; p=0.04). The obstructive apnea index was reduced from 8.3±12.6 to 0.1±0.3 (p=0.1) and the central apnea index was reduced from 5.1±4.7 to 3.1±3.5 (p=0.05). The hypopnea index was unchanged (30.5±13.2 to 29.4±17.5). Oxygenation nadir improved from 79.5±5.3% to 82.5±5.9%; p=0.1, and time spent with oxygenation below 88% was reduced from 4.3±6.8% to 0.9±1.3%; p=0.1. Importantly, no serious device-related adverse events were reported. Conclusion Initial clinical experience suggests that the NPOP is a promising non-surgical, minimal risk and easy-to-implement approach for the reduction of obstructive apneas in a hard-to-treat population. The device does not require elaborate infrastructure, therefore may additionally have application for lower resource settings. Future work will focus on design modification to not only alleviate obstructive events but also to reduce hypopneas. Support (if any) UM-Coulter Program