Abstract

Abstract Introduction This cross-sectional study evaluated a novel nasal airway stent (NAS) in the form of a single-use, disposable device (naśtent® classic, Seven Dreamers Laboratories, Inc., Tokyo, Japan), which represents a significant advancement in NAS technology for the treatment of OSA. Methods 1353 individuals whom were interested in NAS treatment for their snoring and/or OSA were enrolled in this study conducted in different districts in Tokyo, Japan from 8/21/2015 to 3/7/2016. A total of 1335 participants with complete data were included in the final dataset. Collected data included demographic features, self-reported sleep and OSA characteristics, anatomic traits, Epworth Sleepiness Scale (ESS) scores, and NAS tolerance. Results The majority of the participants were middle-aged men (91.5% male, 45±10.8 years) with normal BMI (24.5±5.7). Self-reported sleep was 9-11 hours (0.1%), 7-9 hours (8.2%), 5-7 hours (66.7%), 3-5 hours (22%), 1-3 hours (1.2%), and unreported (1.9%). Their mean Epworth Sleepiness Scale score was 9±5.56, and their peak Mallampati and tonsillar grading scores were 2/4 and 3/5, respectively. Of the participants, 87.4% were aware of possible OSA either by snoring or by prior diagnosis of OSA, and their reasons for desiring use of NAS therapy presented in a similar ratio. Over 80% of the participants had never been treated for their diagnosis of OSA; for those with current or prior treatment for their OSA, 62.9% reported PAP as their primary therapy, followed by oral appliances (25.7%), surgery (0.5%), and other therapies (10.8%). On a scale of 1 to 5 where 5 indicated good tolerance to the NAS, the mean scores were 4±1.3 for easy of insertion and 4±1.2 for convenience of use. Conclusion This large, cross-sectional study indicated that the majority of individuals seeking a novel NAS treatment for their snoring and/or OSA in Tokyo, Japan were middle-aged men with 5-7 hours of self-reported sleep whom had some daytime sleepiness, displayed signs of mild anatomic upper airway narrowing, had not been treated for their OSA, and whom felt that the NAS was easy and convenient to use. Support Seven Dreamers Laboratories, Inc. and WSS ISRTP

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