Novel Nasal Pillow Mask Designed to Meet CPAP Efficacy and Improve Comfort

Abstract

SESSION TITLE: Aftermath of OSA and Its Treatment SESSION TYPE: Original Investigation Slide PRESENTED ON: Tuesday, October 27, 2015 at 08:45 AM - 10:00 AM PURPOSE: Despite transformative benefits for CPAP in OSA, adherence is quite variable. Complaints include skin irritation, eye puffiness, belching, headache/sinus problems and aesthetic/social complaints. Unlike standard CPAP masks, we are testing a new mask and technology (FRESCA) which delivers low levels of airflow while providing intrapharyngeal pressure hypothesized to maintain upper airway patency. During inhalation, FRESCA entrains room-air minimizing the need for a humidifier. We sought to test FRESCA vs standard CPAP in terms of efficacy. METHODS: To test the viability of this approach we are performing a single-blinded randomized crossover study using standard sleep software. To date, 30 subjects have been enrolled, 25 yielding data from 7 sites. Compliant nasal CPAP users were provided 8 hours sleep opportunity, one night on standard CPAP mask at prescribed pressure and one night on FRESCA mask, same pressure. A blinded RPSGT scored the studies using Medicare criteria (≥4% desaturation). Primary outcomes are Apnea Hypopnea Index(AHI) and Oxygen Desaturation Index(ODI). RESULTS: 25 subjects (17M) are presented with age 53.7±10.1years, and BMI 30.0±3.0kg/m2. In 3 subjects a third night was necessary (one due to sleep<4hrs and two due to high leak). Of the 25 subjects, baseline AHI was 23.8±15.3/h. All enrolled subjects had CPAP levels ranging from 4-14cmH2O. As blinding is maintained we present primary outcomes (AHI and ODI) for Treatment X and Treatment Y. On Treatment Y, the median AHI and ODI respectively were 1/h[0.2,4.6], 0.3/hr[0.2, 3.5]. On Treatment X the median AHI and ODI respectively were 0.7/h[0.2, 2.6] and 0.1/hr[0.0,0.2]. CONCLUSIONS: Thus far, FRESCA has comparable efficacy to standard CPAP. Further efforts will be required to determine whether this new technology will improve comfort while maintaining PAP efficacy for Obstructive Sleep Apnea. CLINICAL IMPLICATIONS: This new mask may play a role in improving PAP adherence. DISCLOSURE: The following authors have nothing to disclose: Pamela DeYoung, Erik Smales, Gary Zammit, Richard Bogan, Delmer Henninger, Wesley Fleming, David Seiden, Imran Sharief, Bret Sherman, Robert Owens, Atul Malhotra No Product/Research Disclosure Information