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Medical Consultation

臨床資訊

什麼是阻塞性睡眠呼吸中止症 (OSA)？

阻塞性睡眠呼吸中止症(OSA)是一種與睡眠相關的呼吸障礙疾病。發生於睡眠時，舌頭或喉嚨後方的軟組織鬆弛塌陷，造成上呼吸道狹窄或阻塞，減少空氣進入肺部，進而導致呼吸暫停。當呼吸中止造成缺氧時，腦部藉由喚醒人體，以回復正常呼吸。患者經常因呼吸中止從睡夢中醒來，醒後回復正常呼吸，如此反反覆覆每晚可達數十至數百次不等，嚴重干擾睡眠，造成白天精神不濟、無法專心，或是極度嗜睡。

睡眠呼吸中止症未接受治療可能造成之影響：

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  • 高血壓

  • 心血管疾病

  • 中風

  • 糖尿病

  • 憂鬱症

  • 癌症

阻塞性睡眠呼吸中止症(OSA)常見症狀：

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  • 鼾聲如雷或打鼾頻繁

  • 旁人觀察到睡眠時呼吸中斷無聲現象

  • 睡眠中突然喘氣或大聲吸氣

  • 白天嗜睡或精神不濟

  • 夜晚失眠或睡眠品質差

  • 夜尿(睡眠中斷起身上洗手間)

  • 記憶力減退、學習能力下降或無法集中精神

  • 性慾下降

  • 暴躁易怒

[ 來源: Markets and Markets, Sleep Apnea Diagnostic & Therapeutic Devices Market, MD 1181 | 2012 ]

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睡眠障礙問題於全球盛行，來自睡眠呼吸中止因素則占了不少比例，而阻塞性睡眠呼吸中止症(OSA)為最常見的一種型態。研究顯示，患有OSA的人口全球約有一億人，而有高達八成未經診斷與治療。

臨床研究

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Journal Paper:

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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., “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
     

  4. 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 
     

  5. 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 
     

  6. 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 
     

  7. 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 
     

  8. 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 
     

  9. 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 
     

  10. 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
     

  11. 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.
     

  12. 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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