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Checking Blood Pressure

임상증거

OSA란?

폐쇄성수면무호흡증(OSA)은 혀와 목 뒤쪽 연조직이 무너져 상부 기도를 막으면서 발생하는 수면 관련 호흡장애다. 이것은 폐로 들어가는 공기의 양을 줄여 호흡이 멈추게 합니다.

OSA 증상

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▪ 코 고는 소리가 크거나 잦음
▪ 숨을 쉴 때 호흡이 멈춘다.
▪ 숨이 막히거나 헐떡이는 소리
▪ 낮의 졸음 또는 피로
▪ 불면증 또는 상쾌하지 않은 수면
▪ 아침 두통
▪ 야뇨증(밤에 일어나 화장실에 간다)
▪ 기억력 또는 학습 문제 및 집중력 상실
▪ 성적 욕구 감소
▪ 과민성

치료되지 않은 수면 무호흡의 장기적인 결과:

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▪ 고혈압
▪ 심장병
▪ 스트로크
▪ 당뇨병 전 및 당뇨병
▪ 우울증
▪ 암

Clinical_OSA分布.png

[ Source: MarketsandMarkets, Sleep Apnea Diagnostic & Therapeutic Devices Market, MD 1181 | 2012 ]

수면 문제는 세계적으로 확산되고 있으며 수면 무호흡증은 이 질환의 결정적인 원인입니다.  폐색성 수면 무호흡증은 수면 무호흡증의 가장 흔한 유형으로, 수면 무호흡증이 있는 사람의 약 84%가 이 질병으로 진단 됩니다. 연구에 따르면 전 세계적으로 약 1억 명의 사람들이 폐쇄성 수면 무호흡증을 가지고 있는 것으로 의심되며, 이 중 80% 이상이 진단되지 않은 상태로 남아 있습니다.

iNAP 환자 결과*
iNAP는...

75%

88%

75%의 임상 성공률
의사의 평가를 통해 88% 대폭 개선(CGI-G)

73%

수면 무호흡증의 평균 73% 감소
Ref:  iNAP® One Pivotal Study
저널게시 목록

저널:

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  1. Ching-Yuan Cheng, Chia-Chi Chen, Men-Tzung Lo, Christian Guilleminault and Chia-Mo Lin,"Evaluation of efficacy and safety of intraoral negative air pressure device in adults with obstructive sleep apnea in Taiwan", Sleep Medicine, Vol.81, pp. 163-168, 2021, https://www.sciencedirect.com/science/article/abs/pii/S1389945721001106?via%3Dihub
     

  2. Yamaguchi Y, “The Effect of Intermittent Negative Air Pressure, iNAP® on Subjective Daytime Sleepiness in Middle-aged Patients with Moderate Obstructive Sleep Apnea,” J. Sleep Disord. Ther., vol.9, Iss.5, no:318. 2020, http://doi.org/10.35248/2167-0277.20.9.318.                                                                                

  3. T. C. Hung et al., “Building a model to precisely target the responders of a novel intermittent negative air pressure device-with mechanism definition”, Sleep Medicine, In Press, 2020, https://doi.org/10.1016/j.sleep.2020.03.014                                                                                                    

  4. T. C. Hung et al., “A novel intermittent negative air pressure device ameliorates obstructive sleep apnea syndrome in adults,” Sleep Breath., vol. 23, no. 3, pp. 849–856, 2019, http://doi.org/10.1007/s11325-018-01778-z
     

  5. Y. Yamaguchi and M. Kato, “Pilot Study of Oral Negative Pressure Therapy for Obstructive Sleep Apnea-Hypopnea Syndrome,” J. Sleep Disord. Ther., vol. 06, no. 03, 2017, http://doi.org/10.4172/2167-0277.1000271 
     

  6. M. Camacho, S. A. Song, and A. M. Tolisano, “Oral pressure therapy (winx) for obstructive sleep apnea: a meta-analysis updating the systematic review,” Sleep Breath., vol. 20, no. 3, pp. 1011–1012, 2016, http://doi.org/10.1007/s11325-016-1350-z 
     

  7. G. Nigam, C. Pathak, and M. Riaz, “Effectiveness of oral pressure therapy in obstructive sleep apnea: a systematic analysis,” Sleep Breath., vol. 20, no. 2, pp. 663–671, 2016, http://doi.org/10.1007/s11325-015-1270-3 
     

  8. R. J. Schwab et al., “Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea,” Sleep, vol. 37, no. 7, pp. 1237–1247, 2014, http://doi.org/10.5665/sleep.3846 
     

  9. I. M. Colrain et al., “A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea,” Sleep Med., vol. 14, no. 9, pp. 830–837, 2013,  http://doi.org/10.1016/j.sleep.2013.05.009 
     

  10. J. G. Park, T. M. Morgenthaler, and P. C. Gay, “Novel and emerging nonpositive airway pressure therapies for sleep apnea,” Chest, vol. 144, no. 6, pp. 1946–1952, 2013, http://doi.org/10.1378/chest.13-0273 
     

  11. M. Farid-Moayer, L. C. Siegel, and J. Black, “Oral pressure therapy for treatment of obstructive sleep apnea: Clinical feasibility,” Nat. Sci. Sleep, vol. 5, pp. 53–59, 2013,  http://doi.org/10.2147/NSS.S44736
     

  12. Farid-Moayer M, Siegel LC, Black J. A feasibility evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. Ther Adv Respir Dis, 2013, 7:3-12. http://doi.org/10.1177/1753465812468043.
     

  13. D. A. Barone, “Alternative devices for obstructive sleep apnea,” Neurol. Clin. Pract., vol. 3, no. 1, pp. 67–70, 2013, http://doi.org/10.1212/CPJ.0b013e318278be88

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Conference Paper:


 

  1. Georg N et al., A Multi-center, Two-stage, Single-arm, Prospective, First-night Order Cross-over, Evaluator-blind Study to Evaluate the Efficacy, Safety and Tolerance of the iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea. 28th DGSM (Deutschen Gesellschaft für Schlafforschung und Schlafmedizin), 2020, Germany.                                                                                                                       

  2. Chia-Chi. Chen, Chen Lin, Chia-Mo Lin, Titration of the intra-oral negative air pressure in treating the patient with obstructive sleep apnea, European Respiratory Society (ERS) International Congress 2020       

  3. Georg N et al., A Multi-center, Two-stage, Single-arm, Prospective, First-night Order Cross-over, Evaluator-blind Study to Evaluate the Efficacy, Safety and Tolerance of the iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)--AN INTERIM ANALYSIS. 27th DGSM (Deutschen Gesellschaft für Schlafforschung und Schlafmedizin), 2019, Germany. 
     

  4. Liu CL et al., Intra-oral negative pressure therapy in patients with obstructive sleep apnea: upper airway imaging in responders vs. nonresponders.  Sleep DownUnder, 2019, Australia.
     

  5. Li HY et al., CPAP離脱者への対応 – How do we manage CPAP failure? 日本睡眠学会第44回定期学術集会, 2019, Japan.
     

  6. Lin CM et al., A Single-center Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of intraoral Negative Air Pressure Device in Adults with Obstructive Sleep Apnea. 33rd Annual Meeting of the Associated Professional Sleep Society, 2019, United States.
     

  7. Liu TJ et al., Upper Airway Imaging of Patients with Obstructive Sleep Apnea under Treatment of a Novel Intra‐Oral Negative Pressure Device. 10th International Surgical Sleep Society Meeting, 2019, United States.
     

  8. Liu CL et al., The effective rationale of a novel intra-oral negative pressure device for obstructive sleep apnea. Sleep DownUnder, 2018, Australia.
     

  9. Liu TJ et al., Follow-up Reports on Intraoral Negative Air Pressure Device Treated Patients Underwent Obstructive Sleep Apnea Uvulopalatopharyngoplasty. 9th International Surgical Sleep Society Meeting, 2018, Germany.
     

  10. Hang LW et al., Treatment Outcomes and Safety of a Novel Intraoral Negative Air Pressure Device in the First-in-Man Study. 2nd Congress of Asian Society of Sleep Medicine, 2018, South Korea.
     

  11. Liu TJ et al., Imaging and Treatment Outcomes of the iNAP® Sleep Therapy System in the Feasibility Study in Taiwan. 14th Taiwan Japan Conference on Otolaryngology Head and Neck Surgery, 2017, Taiwan.
     

  12. Liu TJ et al., An Oral Negative Pressure Device for Treatment Obstructive Sleep Apnea (OSA). 25th DGSM (Deutschen Gesellschaft für Schlafforschung und Schlafmedizin), 2017, Germany.
     

  13. Lin CM et al., A Multicenter Pilot Study on the Indications of the Negative Pressure Sleep Therapy System for the Treatment of Obstructive Sleep Apnea. A Joint Congress of World Association of Sleep Medicine and World Sleep Federation, 2017, Czech Republic.
     

  14. Liu TJ et al., Imaging and Treatment Outcomes of the iNAP® Sleep Therapy System in the Feasibility Study in Taiwan. Network of Asia-Pacific Sleep Specialists, 2016, United States.
     

  15. Lin CM et al., Clinical Efficacy and Safety Evaluation of a Novel Negative Pressure Therapy System for Treatment of Obstructive Sleep Apnea Adult Patients. 4th International Pediatric Sleep Association Congress in conjunction with the 14th annual meeting of Taiwan Society of Sleep Medicine, 2016, Taiwan.
     

  16. Liu TJ et al., Safety and Effectiveness of Intraoral Pressure Gradient Device for Obstructive Sleep Apnea Patients. 6th World Congress on Sleep Medicine, 2015, South Korea.
     

  17. Liu TJ et al., Preliminary result of an oral negative pressure device for treatment obstructive sleep apnea (OSA). 13th Asia-Oceania ORL-HNS Congress, 2015, Taiwan.
     

  18. Emsellem HA et al., Safety and effectiveness of oral pressure therapy with a new oral interface. Sleep, 2014, 37(abstr suppl):A146(4017).
     

  19. Colrain IM et al., Safety and effectiveness of oral pressure therapy: 3-month treatment evaluation. Am J Respir Crit Care Med, 2013, 187:A2119. 
     

  20. Patel SR et al., Am J Respir Crit Care Med, 2013, 187:A3752.
     

  21. Colrain IM et al., Compliance with oral pressure therapy for treatment of obstructive sleep apnea. Sleep, 2013, 36(abstr suppl):A138(0391).
     

  22. Colrain IM et al., Oral pressure therapy for obstructive sleep apnea in subjects without prior treatment experience. Sleep, 2013, 36(abstr suppl):A175(0504).
     

  23. Colrain IM et al., Oral Pressure Therapy: a new treatment for obstructive sleep apnea. Sleep and Biological Rhythms, 2013, 11 (S2):29-30.
     

  24. Malhotra A, et al., Oral pressure therapy improves obstructive sleep apnea. Am J Respir Crit Care Med, 2012, 185:A6810.
     

  25. Schwab RJ et al., Mechanism of action of a novel device using oral pressure therapy (OPT) for the treatment of OSA. Am J Respir Crit Care Med, 2012, 185:A6811.
     

  26. Colrain IM et al., A multicentre evaluation of oral pressure therapy for the treatment of obstructive sleep apnoea: sleep architecture effects. J Sleep Res, 2012, 21(Suppl 1):P696.
     

  27. Colrain IM et al., A Multi-Centre Evaluation of Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnoea. J Sleep Res 2012, 21(Suppl 1):P697.
     

  28. Schwab RJ et al., Examining the mechanism of action of a new device using oral pressure therapy for the treatment of obstructive sleep apnea. J Sleep Res, 2012, 21(Suppl 1):O310.

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