title: Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea.
abstract: BACKGROUND
  Non-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.
  
  
  METHODS
  Between 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.
  
  
  RESULTS
  A 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.
  
  
  CONCLUSIONS
  NIV 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.
  
  
  BACKGROUND
  NCT01405976; results.
authors.affiliation: San Pedro de Alcántara Hospital, Cáceres, Spain Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Masa
authors.affiliation: San Pedro de Alcántara Hospital, Cáceres, Spain Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
authors.forename: Jaime
authors.initials: J
authors.lastname: Corral
authors.affiliation: Virgen del Rocío Hospital, Sevilla, Spain.
authors.forename: Candela
authors.initials: C
authors.lastname: Caballero
authors.affiliation: Virgen del Rocío Hospital, Sevilla, Spain.
authors.forename: Emilia
authors.initials: E
authors.lastname: Barrot
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain University Hospital, Burgos, Spain.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Terán-Santos
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain University Hospital, Burgos, Spain.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Alonso-Álvarez
authors.affiliation: IIS Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Gomez-Garcia
authors.affiliation: Valdecilla Hospital, Santander, Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: González
authors.affiliation: Gregorio Marañon Hospital, Madrid, Spain.
authors.forename: Soledad
authors.initials: S
authors.lastname: López-Martín
authors.affiliation: Gregorio Marañon Hospital, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: De Lucas
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Miguel Servet Hospital, Zaragoza, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Marin
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Valld'Hebron Hospital, Barcelona, Spain.
authors.forename: Sergi
authors.initials: S
authors.lastname: Marti
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Doce de Octubre Hospital, Madrid, Spain.
authors.forename: Trinidad
authors.initials: T
authors.lastname: Díaz-Cambriles
authors.affiliation: San Juan Hospital, Alicante, Spain.
authors.forename: Eusebi
authors.initials: E
authors.lastname: Chiner
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Sleep Unit and Respiratory Department, Alava University Hospital IRB, Vitoria, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Egea
authors.affiliation: Araba Health Research Unit, Osakidetza, Alava Hospital, Spain.
authors.forename: Erika
authors.initials: E
authors.lastname: Miranda
authors.affiliation: Department of Medicine, Section of Pulmonary and Critical Care, University of Chicago, Chicago, Illinois, USA.
authors.forename: Babak
authors.initials: B
authors.lastname: Mokhlesi
authors.affiliation: San Pedro de Alcántara Hospital, Cáceres, Spain.
authors.forename: Estefanía
authors.initials: E
authors.lastname: García-Ledesma
authors.affiliation: Virgen del Puerto Hospital, Plasencia, Spain.
authors.forename: M-Ángeles
authors.initials: MÁ
authors.lastname: Sánchez-Quiroga
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain University Hospital, Burgos, Spain.
authors.forename: Estrella
authors.initials: E
authors.lastname: Ordax
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain IIS Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: Nicolás
authors.initials: N
authors.lastname: González-Mangado
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain IIS Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: Maria F
authors.initials: MF
authors.lastname: Troncoso
authors.affiliation: Valdecilla Hospital, Santander, Spain.
authors.forename: Maria-Ángeles
authors.initials: MÁ
authors.lastname: Martinez-Martinez
authors.affiliation: Valdecilla Hospital, Santander, Spain.
authors.forename: Olga
authors.initials: O
authors.lastname: Cantalejo
authors.affiliation: Gregorio Marañon Hospital, Madrid, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Ojeda
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Miguel Servet Hospital, Zaragoza, Spain.
authors.forename: Santiago J
authors.initials: SJ
authors.lastname: Carrizo
authors.affiliation: Miguel Servet Hospital, Zaragoza, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Gallego
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Valld'Hebron Hospital, Barcelona, Spain.
authors.forename: Mercedes
authors.initials: M
authors.lastname: Pallero
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Valld'Hebron Hospital, Barcelona, Spain.
authors.forename: M Antonia
authors.initials: MA
authors.lastname: Ramón
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Doce de Octubre Hospital, Madrid, Spain.
authors.forename: Josefa
authors.initials: J
authors.lastname: Díaz-de-Atauri
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Doce de Octubre Hospital, Madrid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Muñoz-Méndez
authors.affiliation: San Juan Hospital, Alicante, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Senent
authors.affiliation: San Juan Hospital, Alicante, Spain.
authors.forename: Jose N
authors.initials: JN
authors.lastname: Sancho-Chust
authors.affiliation: Sleep Unit and Respiratory Department, Alava University Hospital IRB, Vitoria, Spain.
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Ribas-Solís
authors.affiliation: Virgen del Rocío Hospital, Sevilla, Spain.
authors.forename: Auxiliadora
authors.initials: A
authors.lastname: Romero
authors.affiliation: Virgen de la Macarena Hospital, Sevilla, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Benítez
authors.affiliation: Virgen de la Macarena Hospital, Sevilla, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Sanchez-Gómez
authors.affiliation: Lucus Augusti Universitary Hospital, Lugo, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Golpe
authors.affiliation: La Paz Hospital, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Santiago-Recuerda
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain Arnau de Vilanova Hospital, Lleida, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Gomez
authors.affiliation: University Hospital, Las Palmas, Spain.
authors.forename: Mónica
authors.initials: M
authors.lastname: Bengoa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000502:physiology; D002245:Carbon Dioxide / Q000097:blood; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D063087:Noninvasive Ventilation / Q000379:methods*; D010845:Obesity Hypoventilation Syndrome / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D010313:Partial Pressure; D017286:Polysomnography; D012129:Respiratory Function Tests / Q000379:methods; D020181:Sleep Apnea, Obstructive / Q000150:complications; D016896:Treatment Outcome; D014797:Vital Capacity / Q000502:physiology
chemical_list: D002245:Carbon Dioxide
keywords: Non invasive ventilation; Sleep apnoea