Obstructive Sleep Apnea and a Comprehensive Remotely Supervised Rehabilitation Program: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Obstructive sleep apnea (OSA) is characterized by recurrent intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the quality of the patient's daily life (QoL). Middle-aged and older men who smoke and suffer from obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the standard treatment, various rehabilitation methods also appear to be effective. OBJECTIVE This study aims to evaluate if comprehensive home-based remotely supervised rehabilitation program (tele-RHB program) in combination with standard therapy improves severity, objectives parameters and subjective perception in male participants with OSA. METHODS This randomized controlled trial aims to recruit 50 male participants between the ages of 30-60 years with newly diagnosed OSA. Participants will be randomized 1:1 either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a One year follow-up. The primary outcomes will be the apnea-hypopnea index, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey score, percentage of body fat, six minute walk test distance covered, and maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include values of other selected polysomnographic parameters, anthropometric measurements of neck, waist, hip circumference and body mass index values, forced vital capacity, and forced expiratory volume in 1 second, WHOQOL - BREF score and lipid profile values. RESULTS Study recruitment began on October 25, 2021, and estimated study completion is expected on December 2024. Analyses will be performed to examine whether the combination of tele-RHB program and CPAP therapy will be more effective in reduction of OSA severity, improvement of QoL, body composition, and circumferences, exercise tolerance, lipid profile, and respiratory muscle and lung function compared to CPAP therapy alone. CONCLUSIONS The study will evaluate the effect of comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based option for OSA. CLINICALTRIAL ClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456