Noseda 2004.
Methods | Randomised, single‐blind, cross‐over study. Method of randomisation: random numbers table. Statistical analysis: student's t test (paired data) |
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Participants | N = 27 participants (23 M/4 F). Withdrawals: 3. Total completed and analysed N = 24. Mean age: 49 years; BMI: 32.3 kg/m2; AHI: 50.9; ESS 10.7 Inclusion criteria: AHI > 20/hour; MAI: > 30/hour; high variability of within night pressure to correct AHI Exclusion criteria: prior treatment with CPAP; central OSA/Cheyne Stokes; major facial abnormality; night/shift work; severe chronic heart failure/COPD; seizure disorder; mental retardation; sedative, hypnotic or antidepressant therapy; previous UPPP; prolonged hypoventilation during REM |
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Interventions | Auto‐CPAP versus fixed CPAP. Need for pressure assessed over a 14‐night run‐in period with auto‐CPAP. No washout period described Study duration: 2 x 8‐week treatment periods |
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Outcomes |
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Funding & conflicts of interest statements | Not provided | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation tables |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Quote: ".....single‐blind, randomized, crossover trial........subjects were told that they would sleep with the machine functioning in two distinct modes.....no further explanation was given." |
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 | High risk | Single‐blind nature of the study means that these outcomes are at risk of bias |
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 | Rate of participants not crossing over could be high enough to introduce bias |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |