Sleep is a crucial aspect of health and quality of life, and disturbed or impaired sleep can be both a primary disorder and a symptom of another disease. Sleep research has come a long way in scientific advancement, but the adoption and acceptance of digital health technologies (DHTs) to measure sleep is still very low in regulated clinical trials. This is due in part to a lack of fit-for-purpose validation in the clinical populations.
ActiGraph launched the Digital Endpoint Accelerator Research “DEAR” Grant to help address these evidence gaps by partnering with clinical researchers on projects that examine the validity of digital measures as compared to established ground truth measures. One of the researchers receiving this grant is Sarika Peters, PhD, a psychologist and co-director of the Behavioral Phenotyping Core of the Vanderbilt Intellectual and Developmental Disabilities Research Center.
Dr. Peters has been using wearable sensors to track sleep and activity in Down Syndrome (DS), Rett Syndrome, and Rett-related disorders. Her main area of research focus has been detailed behavioral and neurophysiological characterization of neurogenetic disorders with overlapping intellectual disability.
Disrupted sleep and obstructive sleep apnea are among the most common and burdensome co-occurring conditions in DS, and despite pediatric guidelines suggesting that all children with DS should undergo polysomnography (PSG) by age 4, this recommendation is often not met due to challenges with feasibility and practicality in many situations. Wrist-worn actigraphy devices can be used to estimate sleep parameters with automated algorithms, but more studies are needed to demonstrate its use as a valid, reliable, and meaningful endpoint for sleep quality in DS.
With the DEAR Grant, Dr. Peters and ActiGraph will develop a specific algorithm for measuring sleep-based outcomes in DS against the gold standard sleep assessment, PSG. This approach will help determine whether actigraphy can be used more broadly to diagnose and monitor sleep problems and whether it could be applied in future DS clinical trials.
This research project is one of five that have been selected to receive the DEAR Grant, all of which will progress over the course of 2023. Evidence generated from these studies will accelerate the adoption of wearable data as patient-centered outcomes, which will ultimately improve clinical trial efficiency.