Digital sleep clinic: assessing efficacy of continuous positive airway pressure through sleep staging via connected devices: a study protocol

Abstract

BackgroundObstructive sleep apnea (OSA) is a multisystemic chronic disease with disabling symptoms, cardiometabolic comorbidities and reduction in physical activity. Continuous positive airway pressure (CPAP) is the standard treatment for OSA. Only a few studies have characterized trajectories of sleep parameters upon initiation of CPAP and these are limited to one or two nights of polysomnographic recording in a sleep laboratory. This is due to the cost of carrying out these studies and poor tolerance by patients of multiple nights of polysomnographic recordings. No study has characterized sleep over multiple nights before and after CPAP initiation, assessing the multidimensional efficacy of CPAP on patient reported outcomes, objective and subjective sleep quality, oximetry, glucose control and physical activity.New digital technologies enable overnight sleep studies over several nights in the patient’s home, with a reliability of sleep characterization equivalent to polysomnographic recording.The primary aim of this study is to investigate objective slow wave sleep (SWS or N3) quality before CPAP and during the first month of the treatment.Secondary objectives are to assess changes in the following parameters before CPAP and during the first month of the treatment: other objective sleep parameters and sleep stages evolution (W, N1, N2 and REM), nocturnal oxygen desaturations, 24-h blood glucose profile, daily physical activity (the daily steps count), and patient reported outcomes.MethodsSeventy patients prescribed CPAP for OSA will be recruited at Grenoble Alpes University Hospital (France) and monitored for 5 weeks using validated innovative wearable connected devices (the Dreem 3 headband, a pedometer, an oximeter, and a continuous glucose sensor) enabling them to track their own sleep and physiological parameters at home before and after CPAP initiation.DiscussionBy pooling data from the CPAP telemonitoring and other connected devices we should be able to follow the multidimensional trajectories of patients after the initiation of CPAP. This will enable us to determine whether objective changes in sleep parameters in the first few weeks of CPAP treatment are associated with improvements in daytime sleepiness, quality of life, treatment adherence, glucose control and physical activity. The data will provide integrated markers of treatment efficacy and will allow adapted personalized management of OSA in the short and long-term.Trial registrationClinicaltrials (NCT05197855).