Cory J Rubin, Lara W Lee, Amal Assa'ad, Irene Lara-Corrales, Dina Katabi, Hariharan Rahul, Siqiao Ruan, Pranav Krishna, Rumen Hristov, Karen J Chandross, Rajan Gupta, Marius Ardeleanu, Annie Zhang
The Emerald touchless sensor can provide objective measures of itch-related scratching and sleep disturbance in children with AD in a home setting, demonstrating its feasibility for use in pediatric clinical trials.
INTRODUCTION: In children with atopic dermatitis (AD), itch-related nighttime scratching is associated with significant sleep disturbances. The aim of this study is to report the feasibility of using the Emerald touchless sensor to quantify nighttime scratching and sleep patterns in pediatric patients.
METHODS: PEDISTAD EMERALD (NCT05235724), an open-label, 12-week, exploratory study, included 20 pediatric patients with moderate-to-severe AD aged 6-11 years from the PEDISTAD registry (NCT03687359). The Emerald touchless sensor measures sleep onset and efficiency. Correlation analyses were performed between sleep onset and Peak Pruritus Numeric Rating Scale (PP-NRS), scratching events and time per hour and PP-NRS, and weekly averages of nightly scratching events per hour and sleep efficiency.
RESULTS: We show strong statistically significant correlations between sleep onset and PP-NRS (Pearson correlation coefficient: r = 0.50; p = 0.049) and between scratching events per hour and sleep efficiency (r = - 0.66; p = 0.003). Additionally, we observed positive correlations between scratching events (r = 0.46; p = 0.076) and scratching time per hour (r = 0.43; p = 0.096) and PP-NRS that did not reach statistical significance.
CONCLUSIONS: The Emerald touchless sensor can provide objective measures of itch-related scratching and sleep disturbance in children with AD in a home setting, demonstrating its feasibility for use in pediatric clinical trials.
TRIAL REGISTRATION: NCT05235724.