Abstract
In the rapidly evolving landscape of continuous electrocardiogram (ECG) monitoring systems, there is a heightened demand for non-invasive sensors capable of measuring ECGs and detecting heart rate variability (HRV) in diverse populations, ranging from cardiovascular patients to sports enthusiasts. Challenges like device accuracy, patient privacy, signal noise, and long-term safety impede the use of wearable devices in clinical practice. This scoping review aims to assess the performance and safety of novel multi-channel, sensor-based biopotential wearable devices in adults. A comprehensive search strategy was employed on four databases, resulting in 143 records and the inclusion of 12 relevant studies. Most studies focused on healthy adult subjects (n = 6), with some examining controlled groups with atrial fibrillation (AF) (n = 3), long QT syndrome (n = 1), and sleep apnea (n = 1). The investigated bio-sensor devices included chest-worn belts (n = 2), wrist bands (n = 2), adhesive chest strips (n = 2), and wearable textile smart clothes (n = 4). The primary objective of the included studies was to evaluate device performance in terms of accuracy, signal quality, comparability, and visual assessment of ECGs. Safety findings, reported in five articles, indicated no major side effects for long-term/continuous monitoring, with only minor instances of skin irritation. Looking forward, there are ample opportunities to enhance and test these technologies across various physical activity intensities and clinical conditions.