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Original Research: SLEEP DISORDERS |

Noninvasive Ventilation in Mild Obesity Hypoventilation SyndromeNoninvasive Ventilation in Obesity Hypoventilation: A Randomized Controlled Trial

Jean-Christian Borel, PhD; Renaud Tamisier, MD, PhD; Jesus Gonzalez-Bermejo, MD, PhD; Jean-Philippe Baguet, MD, PhD; Denis Monneret, PharmD; Nathalie Arnol, MSc; Pascale Roux-Lombard, MD; Bernard Wuyam, MD, PhD; Patrick Levy, MD, PhD; Jean-Louis Pépin, MD, PhD
Author and Funding Information

From INSERM 1042 (Drs Borel, Tamisier, Levy, Monneret, and Pépin and Ms Arnol), HP2 Laboratory, Université Joseph Fourier, Faculté de Médecine, Grenoble; the Pôle Rééducation et Physiologie (Drs Borel, Tamisier, Wuyam, Levy, and Pépin and Ms Arnol), and the Département de cardiologie (Dr Baguet), CHU, Hôpital A. Michallon, Grenoble; AP-HP (Dr Gonzalez-Bermejo), Groupe hospitalier Pitié-Salpêtrière, Service de Pneumologie et réanimation médicale, Paris; and Service d’Immunologie et d’Allergologie (Dr Roux-Lombard), Hôpitaux Universitaires et Université de Genève, Geneva, Switzerland.

Correspondence to: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, BP217X, 38043 Grenoble cedex 09, France; e-mail: jpepin@chu-grenoble.fr


Funding/Support: This study was supported by unrestricted grants from Covidien (Elancourt, France), the scientific council of ANTADIR (Association Nationale pour le Traitement à Domicile de l’Insuffisance Respiratoire, Paris, France), the scientific council of COMARES (Comité Départemental contre les Maladies Respiratoires de l’Isère, Meylan, France), and the scientific council of AGIR à dom, home care provider (Meylan France).

Drs Levy and Pépin are co-senior authors of this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2012 American College of Chest Physicians


Chest. 2012;141(3):692-702. doi:10.1378/chest.10-2531
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Objective:  Open studies suggest that treatment of obesity hypoventilation syndrome (OHS) by noninvasive ventilation (NIV) restores sleep quality and daytime vigilance and reduces cardiovascular morbidity. However, to our knowledge no randomized controlled trial (RCT) comparing NIV to conservative measures is available in the field. The goal of this study was to assess in patients with OHS, during an RCT, effects of 1-month NIV compared with lifestyle counseling on blood gas measurements, sleep quality, vigilance, and cardiovascular, metabolic, and inflammatory parameters.

Methods:  Thirty-five patients in whom OHS was newly diagnosed were randomized either to the NIV group or the control group represented by lifestyle counseling. Assessments included blood gas levels, subjective daytime sleepiness, metabolic parameters, inflammatory (hsCRP, leptin, regulated upon activation normal T-cell express and secreted [RANTES], monocyte chemoattractant protein-1, IL-6, IL-8, tumor necrosis factor-α, resistin) and antiinflammatory (adiponectin, IL-1-RA) cytokines, sleep studies, endothelial function (reactive hyperemia measured by peripheral arterial tonometry [RH-PAT]), and arterial stiffness.

Results:  Despite randomization, NIV group patients (n = 18) were older (58 ± 11 years vs 54 ± 6 years) with a higher baseline Paco2 (47.9 ± 4.2 mm Hg vs 45.2 ± 3 mm Hg). In intention-to-treat analysis, compared with control group, NIV treatment significantly reduced daytime Paco2 (difference between treatments: −3.5 mm Hg; 95% CI, −6.2 to −0.8) and apnea-hypopnea index (−40.3/h; 95% CI, −62.4 to −18.2). Sleep architecture was restored, although nonrespiratory microarousals increased (+9.4/h of sleep; 95% CI, 1.9-16.9), and daytime sleepiness was not completely normalized. Despite a dramatic improvement in sleep hypoxemia, glucidic and lipidic metabolism parameters as well as cytokine profiles did not vary significantly. Accordingly, neither RH-PAT (+0.02; 95% CI, −0.24 to 0.29) nor arterial stiffness (+0.22 m/s; 95% CI, −1.47 to 1.92) improved.

Conclusions:  One month of NIV treatment, although improving sleep and blood gas measurements dramatically, did not change inflammatory, metabolic, and cardiovascular markers.

Trial registry:  ClinicalTrials.gov; No.: NCT00603096; URL: www.clinicaltrials.gov

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