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

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
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
Interventions Auto‐CPAP versus fixed CPAP. No washout
Study duration: 2 x 12 week treatment periods
Outcomes
  1. Treatment pressure 

  2. Symptoms (ESS)

  3. Machine usage (hours of usage, % nights used effectively & % days used)

  4. AHI

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