Ruhle 2011.
Methods | Randomised, cross‐over study | |
Participants | N = 51 participants (gender breakdown available for 44 completers: 39 M/5 F). Age 51.5; BMI: 30.9 kg/m2; AHI: 43; ESS 10.3 Inclusion criteria: all patients referred with OSA, aged between 30 and 80 and without nasal or throat complaints Exclusion criteria: > 5 central apnoeas per hour of sleep, acute infection, NYHA III or IV heart failure, acute pulmonary embolism or acute coronary syndrome. Previous use of CPAP |
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Interventions | CPAP with heated humidification versus CPAP without heated humidification Study duration: 2 x 4 weeks |
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Outcomes |
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Funding & conflicts of interest statements | Quote: "K‐H. Ruhle and G. Nilius received research funding from Fisher & Paykel Healthcare, Heinen und Löwenstein, ResMed and Weinmann. This funding has gone into department funds. The author's study was supported by a grant from Fisher & Paykel Healthcare Germany GmbH & Co. KG, 73636 Welzheim, Germany.Karl‐Josef Franke and Ulrike Domanski have no financial or other potential conflict of interest associated with this investigation." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study had a randomised, cross‐over design and used a previously prepared randomisation list. |
Allocation concealment (selection bias) | Low risk | Quote: "The patients were told about the group allocation only after consent. The recruiting doctor was blinded to the randomisation." |
Blinding of participants and personnel (performance bias) Machine usage, symptoms, quality of life, withdrawal, adverse effects | High risk | Quote: "However, it must be kept in mind that patients knew when cHH was used and this may impact on the reported symptoms" |
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 | Quote: "The outcome assessor who calculated the study results was not blinded to the allocation." |
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 | Quote: "Fifty one patients were recruited, 7 dropped out during the course of the study, of which 5 were allocated to the humidification group and 2 in the CPAP group.....44 patients completed the study." |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Low risk | No concerns identified |