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Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial.
Wimms, Alison J; Kelly, Julia L; Turnbull, Christopher D; McMillan, Alison; Craig, Sonya E; O'Reilly, John F; Nickol, Annabel H; Hedley, Emma L; Decker, Meredith D; Willes, Leslee A; Calverley, Peter M A; Benjafield, Adam V; Stradling, John R; Morrell, Mary J.
Afiliación
  • Wimms AJ; Department of Medicine, University of Sydney, Sydney, Australia; ResMed Science Center, ResMed Ltd, Sydney, Australia.
  • Kelly JL; National Heart and Lung Institute, Imperial College London, London, UK; Royal Brompton and Harefield NHS Foundation Trust, London, UK. Electronic address: j.kelly@rbht.nhs.uk.
  • Turnbull CD; Oxford NIHR Biomedical Research Centre, Oxford, UK.
  • McMillan A; Lister Hospital, Stevenage, UK.
  • Craig SE; University Hospital Aintree, Liverpool, UK.
  • O'Reilly JF; University Hospital Aintree, Liverpool, UK.
  • Nickol AH; Oxford University Hospital NHS Foundation Trust, Hospital, Oxford, UK.
  • Hedley EL; Oxford Respiratory Trials Unit, Oxford, UK.
  • Decker MD; Willes Consulting Group, Encinitas, CA, USA.
  • Willes LA; Willes Consulting Group, Encinitas, CA, USA.
  • Calverley PMA; Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
  • Benjafield AV; ResMed Science Center, ResMed Ltd, Sydney, Australia.
  • Stradling JR; Oxford NIHR Biomedical Research Centre, Oxford, UK.
  • Morrell MJ; National Heart and Lung Institute, Imperial College London, London, UK; Royal Brompton and Harefield NHS Foundation Trust, London, UK.
Lancet Respir Med ; 8(4): 349-358, 2020 04.
Article en En | MEDLINE | ID: mdl-31806413
ABSTRACT

BACKGROUND:

The evidence base for the treatment of mild obstructive sleep apnoea is limited and definitions of disease severity vary. The MERGE trial investigated the clinical effectiveness of continuous positive airway pressure in patients with mild obstructive sleep apnoea.

METHODS:

MERGE, a multicentre, parallel, randomised controlled trial enrolled patients (≥18 years to ≤80 years) with mild obstructive sleep apnoea (apnoea-hypopnoea index [AHI] ≥5 to ≤15 events per h using either AASM 2007 or AASM 2012 scoring criteria) from 11 UK sleep centres. Participants were assigned (11) to either 3 months of continuous positive airway pressure plus standard care (sleep counselling), or standard care alone, by computer-generated randomisation; neither participants nor researchers were blinded. The primary outcome was a change in the score on the Short Form-36 questionnaire vitality scale in the intention-to-treat population of patients with mild obstructive sleep apnoea diagnosed using the American Academy of Sleep Medicine 2012 scoring criteria. The study is registered with ClinicalTrials.gov, NCT02699463.

FINDINGS:

Between Nov 28, 2016 and Feb 12, 2019, 301 patients were recruited and randomised. 233 had mild obstructive sleep apnoea using AASM 2012 criteria and were included in the intention-to-treat

analysis:

115 were allocated to receive continuous positive airway pressure and 118 to receive standard care. 209 (90%) of these participants completed the trial. The vitality score significantly increased with a treatment effect of a mean of 10·0 points (95% CI 7·2-12·8; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (9·2 points [6·8 to 11·6] vs -0·8 points [-3·2 to 1·5]). Using the ANCOVA last-observation-carried-forward analysis, a more conservative estimate, the vitality score also significantly increased with a treatment effect of a mean of 7·5 points (95% CI 5·3 to 9·6; p<0·0001) after 3 months of continuous positive airway pressure, compared with standard care alone (7·5 points [6·0 to 9·0] vs 0·0 points [-1·5 to 1·5]). Three serious adverse events occurred (one allocated to the continuous positive airway pressure group) and all were unrelated to the intervention.

INTERPRETATION:

3 months of treatment with continuous positive airway pressure improved the quality of life in patients with mild obstructive sleep apnoea. These results highlight the need for health-care professionals and providers to consider treatment for patients with mild obstructive sleep apnoea.

FUNDING:

ResMed Ltd.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Consejo / Apnea Obstructiva del Sueño / Presión de las Vías Aéreas Positiva Contínua / Nivel de Atención Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Lancet Respir Med Año: 2020 Tipo del documento: Article País de afiliación: Australia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Consejo / Apnea Obstructiva del Sueño / Presión de las Vías Aéreas Positiva Contínua / Nivel de Atención Tipo de estudio: Clinical_trials Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Lancet Respir Med Año: 2020 Tipo del documento: Article País de afiliación: Australia