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. 2019 Dec 2;2019(12):CD003531. doi: 10.1002/14651858.CD003531.pub4

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
Interventions ABRP‐PAP versus fixed CPAP
Study duration: 12 weeks
Outcomes
  1. Machine usage (average hours used)

  2. AHI

  3. Symptoms (ESS)

  4. Withdrawals

  5. Treatment pressure

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."
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