Nilius 2006.
Methods | Randomised, parallel group trial | |
Participants | N = 51 participants; mean age: 57 years; AHI: 53.3 Inclusion criteria: AHI > 20 Exclusion criteria: Inability to follow instructions, failure to give informed consent, acute infection, acute cardiac disease such as acute coronary artery syndrome, NYHA grade 3 or 4 heart failure, and acute pulmonary thromboembolism |
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Interventions | CPAP with expiratory pressure relief versus fixed CPAP Study duration: 7 weeks |
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Outcomes |
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Funding & conflicts of interest statements | Quote: "This study was financed by a gift from Heinen U. Lowenstein. Dr. Ruhle has received research funding from Fisher A. Paykel, Heinen U. Lowenstein, ResMed, and Weinmann, but this funding has gone into department funds. Dr. Nilius, Andreas Happel, and Ulrike Domanski have reported to the ACCP that no significant conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Information not available; requested |
Allocation concealment (selection bias) | Low risk | Third party responsible for randomisation and setting machines to relevant treatment mode |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "The patients were informed that they would receive two different forms of treatment .....but were given no further details...........The technician had no information from the investigators about the modality that the patients were receiving" |
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: "The physician and technicians reviewing the polysomnographic data and performing the manual CPAP titration were blinded to the treatment mode employed" |
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 | All participants accounted for in analysis |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |