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

Senn 2003.

Methods Randomised, cross‐over study. Method of randomisation not reported.
Statistical methods: ANOVA. Unclear how within subject design accounted for in analysis.
Participants N = 31 participants. Withdrawals: N = 2. (23 M/6 F). Mean age: 53 years; BMI: 33.3 kg/m2; AHI: 45.8; ESS: 14.2
Inclusion criteria: AHI > 10 per hour; CPAP‐naive
Interventions Auto‐CPAP (DeVilbiss ‐ response to apnoeas and snoring) and AutoSet T ‐ response to apnoea and snoring + flow limitation) versus fixed CPAP
Study duration: 2‐week run‐in with either auto‐CPAP device. 3 x 4 week treatment periods.
Outcomes

  1. Machine usage (average hours used)

  2. Quality of life (SF‐36: vitality subdomain)

  3. Symptoms (ESS)

  4. Sleep latency

  5. AHI

  6. Treatment pressure
Funding & conflicts of interest statements Quote: "Supported by the Lung League of Zurich, Lung League of Schaffhausen, Lamprecht AG & Labhardt AG".
Author conflicts not provided.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Described as randomised; no other information 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 Single‐blind, cross‐over study. Quote: "Patients...... were blinded to exact study purpose and treatment modes."
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 attrition rate (2 participants/31); reasons for missing data given as lack of time (N = 1), and moving away from area (N = 1)
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk No concerns identified