Sériès 2001.
Methods | Randomised, parallel group trial | |
Participants | N = 48. 40 had previously participated in other trials of auto and fixed CPAP. Mean age: 48; BMI: 39.5 kg/m2 Inclusion criteria: PSG‐diagnosed OSA Exclusion criteria: corrective surgery for OSA |
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Interventions | Auto‐CPAP (Morphée) versus fixed CPAP Study duration: 3 weeks |
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Outcomes |
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Funding & conflicts of interest statements | Not provided | |
Notes | TJL emailed for details of randomisation and outcome data 8 September 2008. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence |
Allocation concealment (selection bias) | Low risk | Quote: "This was done using a binary randomisation list provided by our statistician who was not involved in the study." |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Some participants had previously participated in a study and could have become aware of different devices irrespective of masking treatment group assignment |
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 | Some participants had previously participated in a study and could have become aware of different devices irrespective of masking treatment group assignment |
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 | Low risk | Most outcomes in this review unaffected by the following exclusions: Quote: "The sleep stage‐ and body position‐dependence could not be characterized in 15 patients who did not change body position or whose sleep architecture did not include REM sleep during baseline sleep recording. These subjects were therefore excluded from the comparison between sleep stages/body position‐dependent and independent patients." |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |