A novel intermittent negative air pressure device ameliorates obstructive sleep apnea syndrome in adults
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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.
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.
Thirty-five patients were enrolled: age 41.9 ± 12.2 years (mean ± standard deviation), BMI 26.6 ± 4.3 kg/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 25 kg/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.
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.
KeywordsObstructive sleep apnea syndrome Sleep-disordered breathing Apnea–hypopnea index Intermittent negative air pressure Intraoral device Oral pressure therapy
Conception and design of this manuscript: T.C. Hung, C. Guilleminault
Acquisition of data: T.J. Liu, W. Y. Hsieh, B.N. Chen, W.K. Su
Analysis and/or interpretation of data: T.C. Hung
Drafting and revision of the manuscript: T.C. Hung
Revising and reviewing the manuscript for final releasing: K.H. Sun, C. Guilleminault
This study was sponsored by Somnics, Inc.
Compliance with ethical standards
The study was approved by the MacKay Memorial Hospital Institutional Review Board and registered to the National Department of Health. The study was performed in accordance with applicable local regulations, International Conference on Harmonization Guidelines as well as the 1964 Declaration of Helsinki and its later amendments. All subjects were properly informed and consented to participate in this study.
Conflict of interest
T.C. Hung is employed by Somnics, Inc., and is currently a PhD student at National Yang-Ming University. Besides T.C. Hung, the other authors declare that they have no conflict of interest.
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