Feasibility of a decentralised trial of sleep apnoea screening in patients with atrial fibrillation.
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.
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.
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.
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.
The Danish Heart Foundation (2023-12410) and Helsefonden (20-B-0269).
NCT06188247.
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.
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.
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.
The Danish Heart Foundation (2023-12410) and Helsefonden (20-B-0269).
NCT06188247.
Authors
Hashiba Hashiba, Al-Alak Al-Alak, Nielsen Nielsen, Kayser Kayser, Nouhravesh Nouhravesh, Elmegaard Elmegaard, El-Chouli El-Chouli, Risom Risom, Frandsen Frandsen, Jennum Jennum, Lamberts Lamberts
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