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

Neill 2003.

Methods Randomised, double‐blind, cross‐over study. Method of randomisation not reported. Statisical test: not reported although exact P values presented for between group tests and confidence interval reported for machine usage.
Participants N = 42 randomised (37 completed study protocol and were analysed). Mean age: 49 years. BMI: 35 kg/m2; RDI: 50; ESS: 12.1
Inclusion criteria: newly diagnosed OSA requiring treatment with CPAP
Exclusion criteria: significant nasal obstruction; requirement for supplemental oxygen
Interventions Humidification in addition to nasal CPAP versus sham humidifier in addition to nasal CPAP
Study duration: 2 x 3‐week treatment periods (3 day washout)
Outcomes

  1. Machine usage (average hours used)

  2. ESS

  3. Upper airway symptoms

  4. Preference
Funding & conflicts of interest statements Quote: "This study was funded by an Otago University Research Grant."
Author declarations not provided (conference abstract)
Notes  
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 Low risk Quote: "The authors attempted to create a placebo humidification arm in which the HC100 was used without the heating unit turned on.........An investigator blinded to research treatment interviewed the patients at the end of each treatment arm..."
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: "An investigator blinded to research treatment interviewed the patients at the end of each treatment arm..."
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 Non‐completers excluded from analysis
Selective reporting (reporting bias) Unclear risk Not possible to determine based on details provided
Other bias Low risk No concerns identified