A novel intermittent negative air pressure device ameliorates obstructive sleep apnea syndrome in adults

  • Tzu-Chun Hung
  • Tien-Jen Liu
  • Wen-Yeh Hsieh
  • Bo-Nien Chen
  • Wen-Ko Su
  • Kuang-Hui SunEmail author
  • Christian Guilleminault
Sleep Breathing Physiology and Disorders • Original Article



Patients with obstructive sleep apnea syndrome (OSAS) have difficulties in compliance with continuous positive airway pressure (CPAP) and the treatment outcome is heterogeneous. We proposed a proof-of-concept study of a novel intermittent negative air pressure (iNAP®) device for physicians to apply on patients who have failed or refused to use CPAP.


The iNAP® device retains the tongue and the soft palate in a forward position to decrease airway obstruction. A full nightly usage with the device was evaluated with polysomnography. Subgrouping by baseline apnea–hypopnea index (AHI) and body mass index (BMI) with different treatment response criteria was applied to characterize the responder group of this novel device.


Thirty-five patients were enrolled: age 41.9 ± 12.2 years (mean ± standard deviation), BMI 26.6 ± 4.3 kg/m2, AHI 41.4 ± 24.3 events/h, and oxygen desaturation index (ODI) 40.9 ± 24.4 events/h at baseline. AHI and ODI were significantly decreased (p < 0.001) by the device. Patients with moderate OSAS, with baseline AHI between 15 to 30 events/h, achieved 64% response rate; and non-obese patients, with BMI below 25 kg/m2, achieved 57% response rate, with response rate defined as 50% reduction in AHI from baseline and treated AHI lower than 20. There were minimal side effects reported.


In a proof-of-concept study, the device attained response to treatment as defined, in more than half of the moderate and non-obese OSAS patients, with minimal side effects.


Obstructive sleep apnea syndrome Sleep-disordered breathing Apnea–hypopnea index Intermittent negative air pressure Intraoral device Oral pressure therapy 


Author contributions

Conception and design of this manuscript: T.C. Hung, C. Guilleminault

Acquisition of data: T.J. Liu, W. Y. Hsieh, B.N. Chen, W.K. Su

Analysis and/or interpretation of data: T.C. Hung

Drafting and revision of the manuscript: T.C. Hung

Revising and reviewing the manuscript for final releasing: K.H. Sun, C. Guilleminault


This study was sponsored by Somnics, Inc.

Compliance with ethical standards

Ethical approval

The study was approved by the MacKay Memorial Hospital Institutional Review Board and registered to the National Department of Health. The study was performed in accordance with applicable local regulations, International Conference on Harmonization Guidelines as well as the 1964 Declaration of Helsinki and its later amendments. All subjects were properly informed and consented to participate in this study.

Conflict of interest

T.C. Hung is employed by Somnics, Inc., and is currently a PhD student at National Yang-Ming University. Besides T.C. Hung, the other authors declare that they have no conflict of interest.


  1. 1.
    Remmers JE, deGroot WJ, Sauerland EK, Anch AM (1978) Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol 44:931–938. Google Scholar
  2. 2.
    Gharibeh T, Mehra R (2010) Obstructive sleep apnea syndrome: natural history, diagnosis, and emerging treatment options. Nat Sci Sleep 2:233–255. Google Scholar
  3. 3.
    de Godoy LBM, Palombini LO, Guilleminault C, Poyares D, Tufik S, Togeiro SM (2015) Treatment of upper airway resistance syndrome in adults: where do we stand? Sleep Sci 8:42–48. CrossRefGoogle Scholar
  4. 4.
    Weaver TE, Sawyer A (2009) Management of obstructive sleep apnea by continuous positive airway pressure. Oral Maxillofac Surg Clin North Am 21:403–412. CrossRefGoogle Scholar
  5. 5.
    Certal VF, Zaghi S, Riaz M, Vieira AS, Pinheiro CT, Kushida C, Capasso R, Camacho M (2015) Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope 125:1254–1264. CrossRefGoogle Scholar
  6. 6.
    Marklund M (2017) Update on oral appliance therapy for OSA. Curr Sleep Med Rep 3:143–151. CrossRefGoogle Scholar
  7. 7.
    Epstein LJ, Kristo D, Strollo PJ Jr et al (2009) Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 5:263–276 Google Scholar
  8. 8.
    Yamaguchi Y, Kato M (2017) Pilot study of oral negative pressure therapy for obstructive sleep apnea-hypopnea syndrome. J Sleep Disord Ther 6:271. CrossRefGoogle Scholar
  9. 9.
    Iber C (2007) The AASM manual for the scoring of sleep and associated events: rules, terminology, and technical specifications. J Clin Sleep Med IL, American Academy of Sleep MedicineWestchesterGoogle Scholar
  10. 10.
    WHO (1998) Executive summary of the clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. Arch Intern Med 158:1855–1867. CrossRefGoogle Scholar
  11. 11.
    Pan WH, Yeh WT (2008) How to define obesity? Evidence-based multiple action points for public awareness, screening, and treatment: an extension of Asian-Pacific recommendations. Asia Pac J Clin Nutr 17:370–374 Google Scholar
  12. 12.
    Almeida FR, Bansback N (2013) Long-term effectiveness of oral appliance versus CPAP therapy and the emerging importance of understanding patient preferences. Sleep 36:1271–1272. CrossRefGoogle Scholar
  13. 13.
    Sutherland K, Phillips CL, Cistulli PA (2015) Efficacy versus effectiveness in the treatment of obstructive sleep apnea: CPAP and oral appliances. J Dent Sleep Med 2:175–181. CrossRefGoogle Scholar
  14. 14.
    Schmidt-Nowara W, Lowe A, Wiegand L, Cartwright R, Perez-Guerra F, Menn S (1995) Oral appliances for the treatment of snoring and obstructive sleep apnea: a review. Sleep 18:501–510 CrossRefGoogle Scholar
  15. 15.
    Hoffstein V (2007) Review of oral appliances for treatment of sleep-disordered breathing. Sleep Breath 11:1–22. CrossRefGoogle Scholar
  16. 16.
    Gray EL, McKenzie DK, Eckert DJ (2017) Obstructive sleep apnea without obesity is common and difficult to treat: evidence for a distinct pathophysiological phenotype. J Clin Sleep Med 13:81–88. CrossRefGoogle Scholar
  17. 17.
    Farid-Moayer M, Siegel LC, Black J (2013) A feasibility evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. Ther Adv Respir Dis 7:3–12. CrossRefGoogle Scholar
  18. 18.
    Farid-Moayer M, Siegel LC, Black J (2013) Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility. Nat Sci Sleep 5:53–59. CrossRefGoogle Scholar
  19. 19.
    Colrain IM, Black J, Siegel LC, Bogan RK, Becker PM, Farid-Moayer M, Goldberg R, Lankford DA, Goldberg AN, Malhotra A (2013) A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. Sleep Med 14:830–837. CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Tzu-Chun Hung
    • 1
  • Tien-Jen Liu
    • 2
    • 3
  • Wen-Yeh Hsieh
    • 4
  • Bo-Nien Chen
    • 2
  • Wen-Ko Su
    • 5
  • Kuang-Hui Sun
    • 1
    • 6
    Email author
  • Christian Guilleminault
    • 7
  1. 1.Department of Biotechnology and Laboratory Science in MedicineNational Yang-Ming UniversityTaipeiTaiwan
  2. 2.Department of Otolaryngology Head & Neck SurgeryMacKay Memorial Hospital, Taipei BranchTaipeiTaiwan
  3. 3.School of Biomedical EngineeringTaipei Medical UniversityTaipeiTaiwan
  4. 4.Division of Chest MedicineMacKay Memorial Hospital, Hsinchu BranchHsinchuTaiwan
  5. 5.Department of RadiologyMacKay Memorial Hospital, Hsinchu BranchHsinchuTaiwan
  6. 6.Department of Education and ResearchTaipei City HospitalTaipeiTaiwan
  7. 7.Division of Sleep MedicineStanford UniversityRedwood CityUSA

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