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

Gulati 2015.

Methods Prospective, randomised, cross‐over study in patients who were suboptimally compliant with CPAP despite appropriate interventions. Data analysed as paired t test
Participants N = 28 participants (24 M/4 F). Mean Age 56.7 years; BMI 35 kg/m2; ESS 13.2; AHI 35
Inclusion criteria: OSA with AHI > 5, CPAP compliance < 4 hours per night for 6 weeks after CPAP prescription despite technical and educational interventions, symptoms of pressure intolerance
Exclusion criteria: significant airflow obstruction (FEV1/FVC < 60%), pretreatment study showing central sleep apnoea, clinical evidence of congestive heart failure, daytime hypercapnia (PaCO2 > 6.5kPa) or previous prescription of Bi‐PAP
Interventions Bi‐PAP versus new CPAP (brand of fixed CPAP different from the one used prior to study entry)
Study duration: 2 x 4 weeks with 2 weeks washout in‐between
Outcomes

  1. Machine usage (average hours used)

  2. Symptoms (ESS)

  3. Maintenance of wakefulness test

  4. Quality of life (SAQLI)

  5. AHI

  6. Device comfort

  7. Preference
Funding & conflicts of interest statements Funding source: not declared; conflict of interest: none
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Simple randomisation technique was used to allocate patients into different groups."
Allocation concealment (selection bias) Low risk Quote: "(Allocation sequence concealment) was done independently by the research and development officer, so the patients and researchers were not aware of the allocation sequence."
Blinding of participants and personnel (performance bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk Quote: "Neither (participants or research personnel) were blinded as the machines used were different in each arm."
Blinding of participants and personnel (performance bias) 
 AHI, blood pressure, treatment pressure Low risk Outcome assessors were not blinded to treatment allocation, but the outcomes unlikely to be affected by open‐label design.
Blinding of outcome assessment (detection bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk Outcome assessors were not blinded to treatment allocation
Blinding of outcome assessment (detection bias) 
 AHI, blood pressure, treatment pressure Low risk Outcome assessors were not blinded to treatment allocation, but the outcomes unlikely to be affected by open‐label design.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "31 gave consent and were recruited. One developed a stroke during the treatment period (on Bi‐level PAP arm) and 2 others did not complete the study (one of them dropped out after first using Bi‐level PAP and the other after using the new CPAP). These subjects were excluded from the analyses."
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Low risk No concerns identified