d'Ortho 2000.
Methods | Randomised, single‐blind, cross‐over study. Method of randomisation: random sampling number tables (correspondence with trialist). All participants accounted for Data analysis: paired t test where ANOVA significant. T test used for treatment pressure. Analysis on usage not paired t test. |
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Participants | N = 25 participants (22 M/3 F). Mean age 57; mean AHI 57.8 Inclusion criteria: OSA confirmed by PSG; AHI > 10/hr; ATS recommended indication for CPAP treatment |
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Interventions | Auto‐CPAP versus fixed CPAP. No washout period Study duration: 2 x 4 week treatment arms |
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Outcomes |
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Funding & conflicts of interest statements | Funded by Institut National de la sante et de la Recherche Medicale & by Nellcor‐Puritan Bennett. No declaration of interests provided. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sampling number tables |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Quote: "Patients were not aware of the order of administration (i.e. they were blinded to the setting mode until the first night of use after which they could easily guess which mode they were using.).........The questionnaire was completed with the help of sleep laboratory technicians who were unaware of CPAP mode." |
Blinding of participants and personnel (performance bias) AHI, blood pressure, treatment pressure | Low risk | Awareness of treatment group assignment unlikely to affect objective outcome data from the study |
Blinding of outcome assessment (detection bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Quote: "Patients were not aware of the order of administration (i.e. they were blinded to the setting mode until the first night of use after which they could easily guess which mode they were using.).........The questionnaire was completed with the help of sleep laboratory technicians who were unaware of CPAP mode." |
Blinding of outcome assessment (detection bias) AHI, blood pressure, treatment pressure | Low risk | Awareness of treatment group assignment unlikely to affect objective outcome data from the study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |