The aim of this trial is to compare two different ways of CPAP titration: CAP titration with fixed pressure vs. auto-titrating CPAP.
Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Fixed CPAP or APAP titration at home
UZ Leuven
Leuven, Belgium
CPAP adherence
Usage of the device (mean number of hours/day)
Time frame: 3 months
Effective pressure level
Optimal pressure of CPAP therapy
Time frame: 2 weeks
Residual apnea/hypopnea index
Residual respiratory events during treatment with optimal CPAP pressure during PSG
Time frame: 2 weeks
Mask leaks
Objective leaks (L/min) during CPAP treatment
Time frame: 2 weeks
Proportion of good titration
Number of patients with residual AHI \< 10 (objectivated with PSG)
Time frame: 2 weeks
Residual device AHI
Residual AHI as determined from device data
Time frame: 3 months
Epworth Sleepiness Scale
Daytime sleepiness (range: 0-24 - higher score means worse outcome)
Time frame: 3 months
Blood pressure
Blood pressure measurement
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality (range: 0-21 - higher score means worse outcome)
Time frame: 3 months
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36-Item Short Form Health Survey
Quality of life (range: 0-100 - higher score means better outcome)
Time frame: 3 months
Hospital contacts
Number of contacts with the hospital
Time frame: 3 months