Garmin® Health and ActiGraph™ Collaborate on Wearable Solutions for Clinical Trials
The Validation of a New Actigraphy System for the Measurement of Periodic Leg Movements in Sleep
- Published on 11/01/2005
The following fundamental research was not performed explicitly using an ActiGraph device. However, the theories developed in this paper are used extensively in ActiGraph’s ActiLife software.
Background and Purpose To determine the accuracy of a new actigraphy system for the measurement of periodic leg movements (PLMs). Continuous measurements of leg movements, made overnight, are essential to diagnose and monitor treatment for PLMs. We have developed the Actiwatch with Cambridge Neuro-Technology Ltd (Cambridge, UK) to detect leg movements consistent with PLMs, to record these movements from both feet over three consecutive nights and to report standard indices of PLMs. We describe three studies designed to validate this device.
Patients and Methods The Actiwatch was assessed on a bench model across a range of movement amplitudes. The level of agreement on individual movements between the Actiwatch and bilateral anterior tibialis electromyography (BATEMG) measures was assessed in 199 epochs from five patients with known PLMs. The ability of the Actiwatch to correctly identify patients with PLMs was assessed in a comparison with polysomnography (PSG) in 50 consecutive patients investigated in the sleep laboratory.
Results The Actiwatch detected all mechanically generated movements (100% sensitivity and 100% specificity) on the bench test. On individual movements BATEMG measurement and the Actiwatch agreed on 94% of epochs. The sensitivity and specificity of the Actiwatch to detect leg movements in severe PLMs as defined by BATEMG (PLMI>or=25) are high (100% sensitive and 97% specific). Our bilateral system gave better agreement with BATEMG than previous systems but the two measures are still not interchangeable.
Conclusions EMG is only a surrogate measure of limb movement and indices measured in this way correlate poorly with symptoms. We have demonstrated that the Actiwatch faithfully records movement, which offers the potential to reassess the relationships between limb movement indices and symptoms. This which offers a convenient and economical alternative to PSG in the study of large populations to increase our understanding of the epidemiology and clinical significance of PLMs.
Original Article: http://www.ncbi.nlm.nih.gov/pubmed/16271695