Danish medical journal · 2025
Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillation.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Hashiba Mads, Al-Alak Ali, Nielsen Sebastian Kinnberg, Kayser Lars, Nouhravesh Nina, Elmegaard Mariam, El-Chouli Mohamed, Risom Signe, Frandsen Rune Asger Vestergaard, Jennum Poul, Lamberts Morten
Аннотация
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.
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.