Telemonitoring‐guided ambulatory fixed CPAP titration versus ambulatory APAP titration in moderate obstructive sleep apnea: A non‐inferiority randomized controlled trial

Abstract

SummaryThe present study aimed to evaluate whether titration of fixed continuous positive airway pressure at home using telemonitoring produces patient outcomes equal to auto‐adjusting positive airway pressure titration at home for patients with moderate obstructive sleep apnea. Patients were randomized with a 1:1 allocation ratio to receive either auto‐adjusting positive airway pressure titration based on the median of the 95th percentile pressure across seven nights or fixed continuous positive airway pressure titration based on a fixed calculated pressure and specific adaptations after telemonitoring of device data after 3 and 7 nights. The results of the ambulatory titration were evaluated with in‐laboratory polysomnography after 2 weeks. We hypothesized that fixed continuous positive airway pressure titration would be non‐inferior to auto‐adjusting positive airway pressure titration in respect to continuous positive airway pressure adherence at a 3‐month follow‐up. A non‐inferiority margin of −0.75 hr was prespecified. One‐hundred and four patients were randomly allocated to fixed continuous positive airway pressure (n = 52) and auto‐adjusting positive airway pressure (n = 52) titration. The mean difference and the 95% confidence intervals in continuous positive airway pressure adherence after 3 months between the two arms were 0.80 (−0.08, 1.69) hr. The non‐inferiority hypothesis was confirmed as the lower one‐sided 97.5% confidence interval for the mean difference was above the prespecified margin. Patients in the fixed continuous positive airway pressure titration arm were titrated at significantly lower pressure level and had a significantly lower amount of average leaks compared with auto‐adjusting positive airway pressure‐titrated patients, while there was no difference in residual obstructive apnea–hypopnea index on polysomnography. Telemonitoring enables ambulatory continuous positive airway pressure titration with fixed pressure that is non‐inferior to ambulatory titration with auto‐adjusting pressure in patients with moderate obstructive sleep apnea.