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Checking Blood Pressure

臨床資訊

​關於 阻塞型睡眠呼吸中止症

阻塞性睡眠呼吸中止症 (OSA) 是睡眠時上呼吸道（包含鼻咽、口咽及喉部）發生反覆性的塌陷，因而堵住呼吸道。未接受治療的患者，一個晚上可能有上百次的呼吸中止事件，這也表示大腦和身體有血液含量不足的情況發生。

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根據國際期刊研究，長期為治療阻塞型睡眠呼吸中止症，罹患高血壓、心血管疾病、中風、糖尿病及憂鬱症的風險較一般人高。

 常見症狀:

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  • 大聲且持續性打呼

  • 睡眠中短暫呼吸暫停

  • 睡眠中抽氣或嗆到

  • 日間疲勞、嗜睡

  • 失眠或睡眠品質不佳

  • 早晨起床頭痛

  • 頻繁夜尿

  • 白天注意力不集中

  • 容易焦躁易怒

共病現象:

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  • 高血壓

  • 心血管疾病

  • 中風

  • 糖尿病

  • 憂鬱

  • 癌症

Clinical_OSA分布.png

 Source: Markets and Markets, Sleep Apnea Diagnostic & Therapeutic Devices Market, MD 1181 | 2012 

根據流行病學統計，睡眠問題日趨嚴重，全世界將近一半人口皆受睡眠問題困擾。阻塞型睡眠呼吸中止症是睡眠問題中最大的隱憂，患病率逐年增加。根據研究，全世界約有 1 億人患有阻塞型睡眠呼吸中止症，其中仍有80%尚未被診斷。

iNAP臨床研究
臨床證實iNAP

75%

88%

       治療成功率
            病人顯著改善率

73%

呼吸中止指數 平均減少比率
Ref:  iNAP® One Pivotal Study
iNAP 論文期刊

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Journal Paper :

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  1. Yu-Hsuan Kuo, Tien-Jen Liu, Feng-Hsiang Chiu, Yi Chang, Chia-Mo Lin, Ofer Jacobowitz, and Ying-Shuo Hsu, “Novel Intraoral Negative Airway Pressure in Drug-Induced Sleep Endoscopy with Target-Controlled Infusion”, Nat Sci Sleep. 2021; 13: 2087–2099. Published online 2021 Nov 24. doi:10.2147/NSS.S327770, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8627897/ .                                                        

  2.  Yang-Ta Tseng, Chu-Jen Kuo, and Chun-Yu Lai, “Evaluating the mechanisms of the innovative negative pressure therapy for obstructive sleep apnea treatment by upper airway dynamic imaging”, Fu-Jen Journal of Medicine, Vol. 19 No. 4, 2021 Nov. DOI： 10.3966/181020932021121904004 
    https://www.airitilibrary.com/Publication/alDetailedMesh?docid=18102093-202112-202201040017-202201040017-30-38 .                                                                                                                                                                                                       

  3. 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
     

  4. 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.                                                                                

  5. 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                                                                                                    

  6. 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
     

  7. 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 
     

  8. 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 
     

  9. 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 
     

  10. 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 
     

  11. 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 
     

  12. 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 
     

  13. 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
     

  14. 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.
     

  15. 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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