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

Damjanovic 2009.

Methods Randomised controlled, parallel group trial
Participants N = 100 participants (78 M/22 F); mean age 57; BMI 31 kg/m2
Inclusion criteria: AHI > 15, with or without corresponding daytime symptoms
Exclusion criteria: 1. global respiratory failure; 2. central sleep apnoea syndrome; 3. severe mental or psychological impairment
Interventions 4 groups. Autoadjusting CPAP with or without intensive support versus fixed CPAP with or without intensive support
Study duration: 9 months
Outcomes

  1. Machine usage (hours of use and % days used)

  2. AHI

  3. Oxygen desaturation index

  4. Symptoms (ESS)

  5. Treatment pressure
Funding & conflicts of interest statements Information not available (link to declarations of interest no longer live)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Pulling mixed and sealed envelopes"
Allocation concealment (selection bias) Low risk Quote: "Pulling mixed and sealed envelopes... At time of recruitment, recruiters were also unaware of allocation."
Blinding of participants and personnel (performance bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk Quote: "Patients were not told about their pressure mode, however, full blinding of pressure delivery was not possible. At time of recruitment, recruiters were also unaware of allocation."
Blinding of participants and personnel (performance bias) 
 AHI, blood pressure, treatment pressure Low risk Awareness of treatment group assignment unlikely to affect objective outcome data from the study
Blinding of outcome assessment (detection bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk Quote: "Outcome assessors were not blinded"
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 No information on withdrawals provided
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No concerns identified