Berry 2014.
Methods | Randomised, open‐label, parallel group, singe‐centre trial | |
Participants | N = 156 participants (145 M/11 F). Age: 59 years; BMI: 36 kg/m2; AHI: 28.5 ESS: 14.8 Inclusion criteria: AHI ≥ 10/hour; ESS ≥ 8; living within 200 miles of treatment centre; age > 18 years Exclusion criteria: previous CPAP therapy; shift work; unstable depression/psychosis; non‐adherence with medication; COPD; uncontrolled hypertension or restless legs syndrome; narcolepsy; supplemental oxygen use; congestive heart failure; nightly narcotic use; hypoventilation; neuromuscular weakness; regular sleep of < 4 hours per night; low baseline SaO2; central apnoea index > 5/hour |
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Interventions | Auto‐CPAP versus home PSG CPAP titration followed by fixed pressure CPAP treatment Study duration: 6 weeks |
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Outcomes |
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Funding & conflicts of interest statements | Quote: "This study was supported by a research grant from the Res Med Foundation and an unrestricted research grant from Philips Respironics. Both grants were made to the North Florida Foundation for Research and Education. The CPAP and APAP equipment were purchased by the VA as part of the routine clinical care of the patients. The PAP setups were performed by clinical PAP respiratory therapists as part of the patient’s usual care. A registered polysomnographic technologist (CPAP titrations) and study coordinator were paid by research funding. The principal investigators received no salary support from research funding. This work was also supported by resources provided by the North Florida/South Georgia Veterans Health System, Gainesville, FL. The contents of this paper do not represent the views of the U.S. Department of Veterans Affairs or the United States Government. The authors have indicated no other financial conflicts of interest. The study was performed at the Malcom Randall VA Medical Center, Gainesville, FL." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient details available to determine process |
Allocation concealment (selection bias) | Low risk | Quote: "The method of randomization was by opening sequential envelopes prepared by the research service." |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Study had open‐label design which likely affects usage, symptoms, quality of life attrition outcomes. |
Blinding of participants and personnel (performance bias) AHI, blood pressure, treatment pressure | Low risk | These 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 | Impact of study design on outcome assessment related to nature of outcome. Usage, AHI and treatment pressure measured from technical readings. Symptoms, quality of life more likely affected by open‐label design. |
Blinding of outcome assessment (detection bias) AHI, blood pressure, treatment pressure | Low risk | Treatment pressure and AHI unlikely to be affected by open‐label design. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Balanced but potentially meaningful dropout which was slightly higher in fixed CPAP group (19/78 versus 12/78). Participants not using machines at clinic visit assumed to be non‐users and assigned values of 0 for usage outcome. Likely to be greater impact on symptoms and quality of life outcomes. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes presented according to details provided on trials registry record. |
Other bias | Low risk | No concerns identified |