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

Massie 2003.

Methods Randomised, single‐blind, cross‐over study. Methods of randomisation not reported. Comparisons between treatment using 2‐way analysis of variance ‐ treatment order as between‐subject factor, and treatment type within‐subject factor
Participants N = 46 participants (36 M/10 F) 1 dropout and 1 data unavailable from machine. Mean age: 49; BMI: 32kg/m2
Inclusion criteria: 18 to 65 years; symptomatic OSA; AHI > 15; > 10 cmH2O to correct AHI
Exclusion criteria: pre‐existing lung disease; awake resting SaO2 < 90%; 10 or more central apnoeas/hr; patients taking medication considered to interfere with sleep respiration
Interventions Auto‐CPAP versus fixed CPAP. No washout period
Study duration: 2 x 6‐week treatment periods
Outcomes

  1. Machine usage (average hours used and % days used)

  2. Treatment pressure

  3. AHI

  4. Quality of life (SF‐36 score reported by domain)

  5. Symptoms (ESS and sleep diary score)
Funding & conflicts of interest statements Supported by a grant from ResMed Corporation. One of the authors (Neil Douglas) declared a role as medical advisor to ResMed
Notes Participants aware that machine usage was monitored; stipend offered for completion of study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Information not available
Allocation concealment (selection bias) Unclear risk Information not available
Blinding of participants and personnel (performance bias) 
 Machine usage, symptoms, quality of life, withdrawal, adverse effects High risk Quote: ".....randomised, single‐blinded, cross‐over study....(patients) were not informed of the type of therapy they were receiving"
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 High risk Single blind study
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 Low rate of non‐completers excluded. One excluded from study and additional participant excluded from analysis of machine usage due to unreadable data.
Selective reporting (reporting bias) Unclear risk All outcomes reported
Other bias Low risk No concerns identified