Patients and study design
OSA
DEL
We performed a randomized, double-blind, placebo-controlled, cross-over, single-center study of the combination of reb-oxy in adults with OSA documented by polysomnography (PSG). Participants were enrolled from July 2020 to October 2020 through our sleep clinic (Istituto Auxologico Italiano, Milan, Italy) and the trial ended when the previously calculated sample size of 16 patients was reached. Participants were randomized (1:1 ratio) to first receive a 4 mg reboxetine plus 5 mg oxybutynin or a matching placebo, and then to switch to the other treatment arm after a washout of 7–10 days. Study participants matching eligibility criteria performed a one-night inpatient PSG test, which served as the baseline measure for AHI. Subjects started taking the study drug the day after the baseline PSG, immediately before bedtime, and continued for 7 days in total. On the final dosing night of each week, participants performed in-lab PSG. The study was approved by the Ethics Committee on 18/02/2020 (approval n. 2020_02_18_03) and by the Italian drug agency AIFA (Agenzia Italiana del Farmaco) on 22/04/2020 (EudraCT n 2019-004917-15) and all methods were performed in accordance with the guidelines and regulations. Informed consent in writing was obtained from all study participants. The study was first registered at ClinicalTrials.gov (NCT04449133) on 26/06/2020.