Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillation.

INTRODUCTION

Atrial fibrillation (AF) prevalence is projected to double in the coming decades, necessitating innovative management strategies. This study evaluated the feasibility of a decentralised clinical trial for home-based sleep apnoea (SA) screening, activity tracking and heart rhythm monitoring in patients with AF.

METHODS

This prospective cohort study enrolled patients with AF without known SA. Participants underwent a 12-week study using three home-monitoring systems: NightOwl for SA evaluation, FibriCheck for heart rhythm monitoring and SENS Motion for activity tracking. Patients completed questionnaires assessing AF-related quality of life, symptom severity, sleep quality and eHealth literacy at baseline and 12 weeks.

RESULTS

The study included 18 patients with AF with a median age of 68.0 (interquartile range: 60.0-71.5) years, 11 (61%) women and 15 (83%) with paroxysmal AF. The study demonstrated high feasibility of remote monitoring, with data completeness rates of 83.3% for SA home evaluations, 97.6% for questionnaires, 91.7% for activity tracking and 88.8% for heart rhythm measurements. A drop-out rate of only 5.6% was recorded.

CONCLUSIONS

The study reports the feasibility of a decentralised digital platform for comprehensive AF patient monitoring. High patient engagement and data completeness suggest that digital health technologies can effectively integrate into clinical trials for patients with AF.

FUNDING: The Danish Heart Foundation (2023-12410) and Helsefonden (20-B-0269).

TRIAL REGISTRATION: NCT06188247.