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. 2019 Dec 2;2019(12):CD003531. doi: 10.1002/14651858.CD003531.pub4

Masa 2015.

Methods Randomised, three‐arm, parallel group 
Participants N = 151 participants entered into treatment groups relevant to this review question (66 M/85 F); age: 60 years; BMI: 44; AHI: 69; ESS: 11
Inclusion criteria: 15‐80 years; AHI: > 30; no other significant sleep disorders (e.g. narcolepsy or restless leg syndrome); correctly executed 30‐minute CPAP/NIV test
Exclusion criteria:  significant comorbidity
Interventions Fixed CPAP versus Non‐invasive ventilation treatment set at bilevel pressure with assured volume. Study assigned to bi‐level PAP comparison. Supplemental oxygen offered if participants met additional criteria (daytime PaO2 < 55 mmHg, with the necessary flow to maintain waking arterial oxygen saturation between 88% and 92% or PaO2 greater than or equal to 55 mmHg for at least 17 h/d).
Third treatment arm consisting of a usual care control was not of interest to this review.
Study duration: 3 years (for hospitalisation and withdrawal outcomes). Other outcome data reported at 8 weeks unless stated.
Outcomes

  1. Machine usage (average hours used)

  2. Blood gas (PaCO2 at 3 months)

  3. Cardiovascular markers (HbA1C, Lipid profile)

  4. Quality of life (FOSQ)

  5. Symptoms (ESS)

  6. Nocturnal oximetry

  7. AHI

  8. Adverse events
Funding & conflicts of interest statements Quote: "Supported by the Instituto de Salud Carlos III (Fondo de Investigaciones Sanitarias, Ministerio de Sanidad y Consumo) grant PI050402, the Spanish Respiratory Foundation 2005 (FEPAR), and Air Liquide Spain."
Funders did not participate in the design or conduct of the study, analysis or interpretation of data, or manuscript preparation.
The authors all declared that they had no conflicts of interest.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: participants "randomized by an electronic database (simple randomization)."
Allocation concealment (selection bias) Unclear risk Insufficient information available to judge.
Blinding of participants and personnel (performance bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk For most outcomes of interest to the review open‐label nature of the study places the study at high risk of performance bias. 
Blinding of participants and personnel (performance bias) 
 AHI, blood pressure, treatment pressure Low risk These outcomes unlikely to be affected by awareness of treatment group.
Blinding of outcome assessment (detection bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk For most outcomes of interest to the review open‐label nature of the study places the study at high risk of detection bias. 
Blinding of outcome assessment (detection bias) 
 AHI, blood pressure, treatment pressure Low risk These outcomes unlikely to be affected by awareness of treatment group.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 10% of participants missing data at 2 months. ITT was undertaken with missing data imputed for secondary outcomes (quote): "following a multiple imputation method with iterative multivariable regression, because the missing  data had characteristics compatible with a missing at random pattern."
Selective reporting (reporting bias) Low risk Outcomes of interest reported in accordance with trial registry record.
Other bias Low risk No other sources of bias identified.