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

Kushida 2011.

Methods A prospective, randomised, double‐blinded, three‐arm, multicenter trial
Participants N = 168 participants (128 M/40 F). Age: 49 years; BMI: 34 kg/m2; AHI: 39; ESS: 11
Inclusion criteria: age 21‐75 years, AHI > 15/hour, able to consent, agreeable to commence CPAP as initial therapy, adequate titration within 2 weeks of enrolment
Exclusion criteria: previous study participation < 30 days, > 1 titration, sedatives, medical/psychiatric illness potentially interfering with CPAP adherence, CPAP exposure < 1 year, chronic respiratory disease, upper airway surgery < 90 days, previous surgery for OSA, non‐OSA sleep disorder, excess alcohol use, shift workers
Interventions Comparing effects of autoadjusting PAP EXPssure relief with autoadjusting PAP and fixed CPAP
Study duration: 6 months (see notes)
Outcomes

  1. Machine usage (average hours used)

  2. AHI

  3. Symptoms (ESS)

  4. Blood pressure

  5. Quality of life (FOSQ)

  6. Withdrawals

  7. Patient preference

  8. Treatment satisfaction

  9. Treatment pressure

  10. Adverse events
Funding & conflicts of interest statements Quote: "Philips Respironics provided funding for this study; Drs. Kushida, Berry, Blau, Fietze, Kryger, Kuna, Pegram, and Penzel received research support for the conduct of this study through contracts between Philips Respironics and their respective institutions. Ms. Crabtree received consulting fees for statistical data analysis from Philips Respironics. Dr. Kushida has received research support from Philips Respironics, ResMed, Ventus Medical, and Pacific Medico. Dr. Berry has received research support from Philips Respironics, ResMed, and Ventus Medical. Dr. Blau has received research support from Philips Respironics, Breas, and Hoffrichter) Dr. Fietze has received research support from Philips Respironics, ResMed, Advanced Sleep Research, Breas, Hoffrichter, and Weinmann. Dr. Kryger has received research support from Ventus, and ResMed. Dr. Penzel has received research support from Philips Respironics, ResMed, Advanced Sleep Research, Breas, Hoffrichter, Somnomedics, and Weinmann."
Notes Patients in APAP group ‐ initially APAP for two weeks followed by fixed CPAP for six months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Urn randomization was used to control for the potentially confounding variables (age, gender, education, AHI, subjective sleepiness)"
Allocation concealment (selection bias) Unclear risk Insufficient information to make judgement
Blinding of participants and personnel (performance bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects Low risk Quote: "The Principal Investigator (PI) and research staff administering questionnaires or interacting with the participant were blinded to randomization and the results of all participant evaluations...participants were blinded to treatment"
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 Low risk Quote: "The Principal Investigator (PI) and research staff administering questionnaires or interacting with the participant were blinded to randomization and the results of all participant evaluations"
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 Low risk Quote: "Fourteen participants did not receive the therapy to which they were randomized, but were included in the intention‐to‐treat analysis."
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No concerns identified