• Juan F Masa, Jaime Corral, Candela Caballero, Emilia Barrot, Joaquin Terán-Santos, Maria L Alonso-Álvarez, Teresa Gomez-Garcia, Mónica González, Soledad López-Martín, Pilar De Lucas, José M Marin, Sergi Marti, Trinidad Díaz-Cambriles, Eusebi Chiner, Carlos Egea, Erika Miranda, Babak Mokhlesi, Spanish Sleep Network, Estefanía García-Ledesma, M-Ángeles Sánchez-Quiroga, Estrella Ordax, Nicolás González-Mangado, Maria F Troncoso, Maria-Ángeles Martinez-Martinez, Olga Cantalejo, Elena Ojeda, Santiago J Carrizo, Begoña Gallego, Mercedes Pallero, M Antonia Ramón, Josefa Díaz-de-Atauri, Jesús Muñoz-Méndez, Cristina Senent, Jose N Sancho-Chust, Francisco J Ribas-Solís, Auxiliadora Romero, José M Benítez, Jesús Sanchez-Gómez, Rafael Golpe, Ana Santiago-Recuerda, Silvia Gomez, and Mónica Bengoa.
• San Pedro de Alcántara Hospital, Cáceres, Spain Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
• Thorax. 2016 Oct 1; 71 (10): 899-906.

BackgroundNon-invasive ventilation (NIV) is an effective form of treatment in patients with obesity hypoventilation syndrome (OHS) who have concomitant severe obstructive sleep apnoea (OSA). However, there is a paucity of evidence on the efficacy of NIV in patients with OHS without severe OSA. We performed a multicentre randomised clinical trial to determine the comparative efficacy of NIV versus lifestyle modification (control group) using daytime arterial carbon dioxide tension (PaCO2) as the main outcome measure.MethodsBetween May 2009 and December 2014 we sequentially screened patients with OHS without severe OSA. Participants were randomised to NIV versus lifestyle modification and were followed for 2 months. Arterial blood gas parameters, clinical symptoms, health-related quality of life assessments, polysomnography, spirometry, 6-min walk distance test, blood pressure measurements and healthcare resource utilisation were evaluated. Statistical analysis was performed using intention-to-treat analysis.ResultsA total of 365 patients were screened of whom 58 were excluded. Severe OSA was present in 221 and the remaining 86 patients without severe OSA were randomised. NIV led to a significantly larger improvement in PaCO2 of -6 (95% CI -7.7 to -4.2) mm Hg versus -2.8 (95% CI -4.3 to -1.3) mm Hg, (p<0.001) and serum bicarbonate of -3.4 (95% CI -4.5 to -2.3) versus -1 (95% CI -1.7 to -0.2 95% CI)  mmol/L (p<0.001). PaCO2 change adjusted for NIV compliance did not further improve the inter-group statistical significance. Sleepiness, some health-related quality of life assessments and polysomnographic parameters improved significantly more with NIV than with lifestyle modification. Additionally, there was a tendency towards lower healthcare resource utilisation in the NIV group.ConclusionsNIV is more effective than lifestyle modification in improving daytime PaCO2, sleepiness and polysomnographic parameters. Long-term prospective studies are necessary to determine whether NIV reduces healthcare resource utilisation, cardiovascular events and mortality.Trial Registration NumberNCT01405976; results.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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