PURPOSE: Patients with obstructive sleep apnea syndrome (OSAS) have difficulties in compliance with continuous positive airway pressure (CPAP) and the treatment outcome is heterogeneous. We proposed a proof-of-concept study of a novel intermittent negative air pressure (iNAP) device for physicians to apply on patients who have failed or refused to use CPAP.METHODS: The iNAP device retains the tongue and the soft palate in a forward position to decrease airway obstruction. A full nightly usage with the device was evaluated with polysomnography. Subgrouping by baseline apnea-hypopnea index (AHI) and body mass index (BMI) with different treatment response criteria was applied to characterize the responder group of this novel device.RESULTS: Thirty-five patients were enrolled: age 41.9±12.2years (mean±standard deviation), BMI 26.6±4.3kg/m2, AHI 41.4±24.3 events/h, and oxygen desaturation index (ODI) 40.9±24.4 events/h at baseline. AHI and ODI were significantly decreased (p<0.001) by the device. Patients with moderate OSAS, with baseline AHI between 15 to 30 events/h, achieved 64% response rate; and non-obese patients, with BMI below 25kg/m2, achieved 57% response rate, with response rate defined as 50% reduction in AHI from baseline and treated AHI lower than 20. There were minimal side effects reported.CONCLUSIONS: In a proof-of-concept study, the device attained response to treatment as defined, in more than half of the moderate and non-obese OSAS patients, with minimal side effects.
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