0442 Progress in the SUPRA Trial for the Treatment of CPAP-intolerant OSA patients: AHI and Safety

Abstract

Abstract Introduction An external collar with ~30cmH2O vacuum applied to the anterior neck can expand the oro- and naso-pharynx and improve Pcrit (Kato et al 2015- PMID: 25614595. The hypothesis of SUPRA (Study Using Negative Pressure to Reduce Apnea - NCT04861038) is that the self-contained vacuum device (aerSleep® II) can treat obstructive sleep apnea (OSA) in those unable to use CPAP. Methods Conducted at 15 sleep centers in the United States, CPAP–intolerant subjects meeting eligibility (age >18 yrs, BMI < 42, and an untreated AHI4% by Nox T3 HSAT of 15-50/hr) were fitted to one of three collar sizes. After a 7-day acclimatization trial, those that showed a >50% reduction in AHI4% to less than 20/hr (“Responders”) and accepted therapy agreed to 6 months of supervised treatment, with final assessments at 6 months. 7-day and 6-month end-points reported here are AHI and safety. Results Of screened subjects, 50.2% were excluded, most frequently due to baseline AHI being too high or, mostly, too low (72%). 110 subjects (59±SD11 years, 43% Female, 84% Caucasian) met study criteria. Following device acclimation, 28 (50%) did not meet 7-day pre-selected on-treatment AHI criteria. In 23 subjects (41%), AHI reduced from 26.6±8.5 to 8.1±5.6 (p=0.001), and these Responders differed from non-responders (AHI from 32.7±13.1 to 26.7±9.4, p=0.06) in regard to reductions in apneas and hypopneas and ODI; non-responders had converted to hypopneas. During the 6-month phase, 7 withdrew consent. In all, local irritation occurred in 29 instances in 28 participants, resolving with 1-3 days of discontinuation, and therapy resumed. Eight have completed 6 months without safety issues, and 7 continued to exceed AHI efficacy endpoints. Conclusion We conclude that the aerSleep II device, with current collar sizes and pressure, can reduce the AHI burden at 7 days and continues for 3-6 months without major safety concerns. Support (if any) Presented for the SUPRA Study Group, supported by Sommetrics Inc, San Diego CA