Primary objective: To explore and quantify the association between nighttime scratching and sleep patterns objectively in pediatric participants with moderate to severe atopic dermatitis (AD) using an innovative Emerald touchless sensor. Secondary objective: To evaluate the feasibility of using the Emerald touchless sensor in a pediatric clinical trial setting.
16 weeks
Study Type
OBSERVATIONAL
Enrollment
18
C2 Research Center, LLC-Site Number:8400071
Montgomery, Alabama, United States
Amedica Research Institute, Inc.-Site Number:8400067
Hialeah, Florida, United States
Eastern Research, Inc.-Site Number:8400032
Hialeah, Florida, United States
Skin Research of South Florida, LLC-Site Number:8400018
Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency
Total no. of scratching events and scratching duration within each sleep stage each night will be calculated. Sleep efficiency: total time spent in a sleep stage (Stage 2, 3 or Rapid Eye Movement (REM) stage) relative to the total time in bed will be expressed as a %. Total time in bed: time from when the person enters the bed area and they become relatively static to waking up for the day. Correlation coefficient will be derived using data pairs from baseline through 12 weeks using evaluable data.
Time frame: Week -1 (baseline) to week 12
Percentage (%) of nights with unusable data
The weekly average values (both baseline and post baseline, Emerald and participant reported) will be considered evaluable if they are based on at least 3 evaluable nightly values. Nights with unusable Emerald data are defined as nights with no data being collected by the device for any reason or the data collected were unevaluable.
Time frame: Week -1 (baseline) to week 12
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Miami, Florida, United States
Michigan Dermatology Institute-Site Number:8400059
Waterford, Michigan, United States
Cincinnati Children's Hospital Medical Center-Site Number:8400017
Cincinnati, Ohio, United States
Medical University of South Carolina-Site Number:8400013
Charleston, South Carolina, United States