Gay 2003.
Methods | Randomised, double‐blind, parallel group trial. Machines had settings: 'Set CPAP'; 'Set NBL' and 'A'. Assessors could alter the settings for safety reasons. Randomisation not reported | |
Participants | N = 27 participants (22 M/5 F). Age: 44 years; BMI: 35 kg/m2; AHI: 43; ESS: 13.8 Inclusion criteria: > 18 years; AHI > 10 and < 100; ability to follow instructions and provide informed consent; willingness to return for follow‐up visit 30 days after random allocation to CPAP/BiPAP; residence within 200 miles of clinic Exclusion criteria: inability to wear a mask; prior surgical treatment for OSA; prior CPAP usage; other significant comorbidities |
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Interventions | Bi‐level PAP versus CPAP. Participants also given instruction via educational video on CPAP and OSA. Study duration: 30 days |
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Outcomes |
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Funding & conflicts of interest statements | Quote: "Dr. Peter Gay received grant support for this study by Respironics Inc. (noted in manuscript)." | |
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: "the technician selected the 'A' mode which in a double‐blinded and selective way, locked in the optimal settings for either CPAP or NBL" |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "the technician selected the 'A' mode which in a double‐blinded and selective way, locked in the optimal settings for either CPAP or NBL.............true identification of the 'A' mode was not revealed until the end of the trial" |
Blinding of participants and personnel (performance bias) AHI, blood pressure, treatment pressure | Low risk | These outcomes unlikely to be affected by study design. |
Blinding of outcome assessment (detection bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | Low risk | Quote: "the technician selected the 'A' mode which in a double‐blinded and selective way, locked in the optimal settings for either CPAP or NBL.............true identification of the 'A' mode was not revealed until the end of the trial" |
Blinding of outcome assessment (detection bias) AHI, blood pressure, treatment pressure | Low risk | These outcomes unlikely to be affected by study design. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Randomisation was performed prior to baseline PSG, after which a number of participants became ineligible. All participants recruited to the 2nd phase completed the study. There were no withdrawals from this study, although the sample reflects a selected population. |
Selective reporting (reporting bias) | High risk | Data on quality of life (FOSQ) were not reported but described as 'equivalent' between two treatment arms. |
Other bias | Low risk | No concerns identified |