Hudgel 2000.
Methods | Randomised, single‐blind, cross‐over study. Method of randomisation: hospital number (odd versus even last digit) Paired t test used for continuous data |
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Participants | N = 60 (53 with OSA and 7 with UARS). 21 withdrawals 2 stopped due to medical complications (not stated) and the rest did not complete the study. Further 6 did not have machine usage data. (21 M/18 F). Total number of OSA patients completing trial is 29. Data analysed for 33 patients which included 4 patients with UARS Mean age: 46 years; AHI 30; BMI: 42 kg/m2 Inclusion criteria: diagnosed OSA or UARS (confirmation by polysomnography) Exclusion criteria: prior CPAP treatment, facial/pharyngeal abnormalities requiring surgery, chronic airways disease necessitating bronchodilator usage, obesity hypoventilation syndrome, shift workers, congestive heart failure, seizure disorder, mental retardation, sedative/antidepressant/hypnotic treatment |
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Interventions | Auto‐CPAP versus fixed CPAP. No washout Study duration: 2 x 12 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) | High risk | Hospital number (odd versus even last digit) |
Allocation concealment (selection bias) | High risk | Study investigators likely to be aware of treatment group assignment |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Study investigators likely to be aware of treatment group assignment |
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 | High risk | Study investigators likely to be aware of treatment group assignment |
Blinding of outcome assessment (detection bias) AHI, blood pressure, treatment pressure | Low risk | These outcomes unlikely to be affected by open‐label design |
Incomplete outcome data (attrition bias) All outcomes | High risk | High withdrawal rate and non‐completers not included in analysis |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No concerns identified |