Blau 2012.
Methods | Randomised, double‐blind, parallel group trial | |
Participants | N = 35 participants (34 M/1 F); Age 54.2 years; BMI 30.9 kg/m2; AHI ≥ 39; ESS: 10.2 Inclusion criteria: 18 to 75 years; AHI ≥ 15; BMI < 45 kg/m²; ability to follow study specific instructions Exclusion criteria: other sleep, cardiac, pulmonary, psychiatric or neurological disorder; previous abuse of alcohol, hypnotics or drugs; previous treatment for OSA (including CPAP); inability to wear a mask |
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Interventions | ABRP‐PAP versus fixed CPAP Study duration: 12 weeks |
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Outcomes |
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Funding & conflicts of interest statements | Quote: "This study was supported by an unrestricted grant from Philips Respironics, Inc. 1001 Murry Ridge Lane, Murrysville, PA, 15668, USA" Conflict of interest quote: "'Dr. Fietze, Prof. Penzel, Dr. Peter and Dr. Blau have received travel grants and honorariums for lecturing from Philips Respironics. The other authors have no significant conflicts of interest with any companies/organizations whose products or services may be discussed in this article." |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "We generated a list of N = 32 uniformly distributed pseudo‐random numbers of either 0 (CPAP) or 1 (Auto bi‐level) by using the Mersenne Twister algorithm" |
Allocation concealment (selection bias) | Low risk | Quote: "The allocation of the patient was told directly via telephone in case of randomisation from an not otherwise involved team member, situated in another campus of our university clinic." |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "Devices were set by the study coordinators who deactivated the LCD display so that the patient and investigators did not become aware of device allocation" Quote: "There were no concrete information about characteristics of these different PAP types in the informed consent" |
Blinding of participants and personnel (performance bias) AHI, blood pressure, treatment pressure | Low risk | Quote: "Devices were set by the study coordinators who deactivated the LCD display so that the patient and investigators did not become aware of device allocation" |
Blinding of outcome assessment (detection bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "The investigator making and analysing the PSG recordings on therapy and other outcome measures did not have access to information from the therapy device within their PSG montage" |
Blinding of outcome assessment (detection bias) AHI, blood pressure, treatment pressure | Low risk | Identical machine appearance unlikely to affect measurement of these outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3 withdrawals after allocation (1 from CPAP group and 2 from ABRP‐PAP group); these patients were not included in analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |