Randerath 2001.
| Methods | Randomised, cross‐over study. ANOVA test with Bonferroni correction used (for differences between baseline and treatment mode, and for differences between treatment mode) | |
| Participants | N = 52 participants (45 M/7 F). Mean age: 54.7 years; BMI: 32.4 kg/m2; AHI 35.1 Inclusion criteria: confirmed OSA by polysomnography Exclusion criteria: prior treatment with CPAP |
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| Interventions | Auto‐CPAP versus fixed CPAP. No washout Study duration: 2 x 6‐week treatment periods 24‐hour telephone helpline was at the disposal of the participants |
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| Outcomes |
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| Funding & conflicts of interest statements | Quote: "The devices were supplied by the Weinmann Company, Hamburg, Germany." No author conflicts provided | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Information not available |
| Allocation concealment (selection bias) | Low risk | Quote: "Only the person who managed the randomisation knew about the order of the treatment modes in the individual patients. This person adjusted the devices to the different treatment modes." |
| Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "Those who did the questioning and cared for the patients in the hospital and sleep laboratory and those who evaluated results of PSG were blinded to the mode of treatment applied.........The patients were not informed about the sequence in which the two treatment modes were applied." |
| 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 | Low risk | Quote: "Those who did the questioning and cared for the patients in the hospital and sleep laboratory and those who evaluated results of PSG were blinded to the mode of treatment applied." |
| 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 | High risk | 5/52 participants withdrew; their data were excluded from analysis |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | No concerns identified |