top of page
Checking Blood Pressure

Klinisches

Was ist OSA

Bei der obstruktiven Schlafapnoe (OSA) handelt es sich um eine schlafbezogene Atmungsstörung, die auftritt, wenn die Zunge und das Weichgewebe im hinteren Rachenraum zusammenfallen und die oberen Atemwege blockieren. Dadurch gelangt weniger Sauerstoff in die Lunge, Atemaussetzer sind die Folge.

Symptome einer OSA:

  • Lautes oder häufiges Schnarchen

  • Unbemerkte Atempausen

  • Erstickte oder keuchende Geräusche

  • Tagesschläfrigkeit oder –müdigkeit

  • Schlafstörungen und nicht erholsamer Schlaf

  • Morgendliche Kopfschmerzen

  • Nykturie (vermehrtes, nächtliches Wasserlassen)

  • Probleme in Gedächtnisleistung und Auffassungsgabe sowie Konzentrationsstörungen

  • Vermindertes sexuelles Verlangen

  • Reizbarkeit

Langfristige Folgen unbehandelter Schlafapnoe:

  • Bluthochdruck

  • Herzerkrankung

  • Schlaganfall

  • Vorstufe von Diabetes und Diabetes

  • Depression

  • Krebs

Clinical_OSA分布.png
Wie es funktioniert
iNAP has...

75%

88%

Clinical Success Rate
Significantly Improved by Physician's Assessment (CGI-G)

73%

Average Reduction in Sleep Apnea Events
Ref:  iNAP® One Pivotal Study
Klinische Studien

Journal Paper:

  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.  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. 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/
     

  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, vol. 72 (2020), pp. 20-27, 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

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.

bottom of page