A Study to Assess the Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of Participants From PEDISTAD Study (OBS15333; NCT03687359)

Study Overview
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Brief Summary
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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.

Detailed Description
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16 weeks

Official Title
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Open-label 12-week Longitudinal Exploratory Study to Assess Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of PEDISTAD Patients

Conditions
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Dermatitis Atopic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites. Enrolled in PEDISTAD, age more than or equal to 6 years to less than 12 years at the time of enrollment. Peak pruritus Numeric Rating Scale (NRS) last night more than or equal to 4 at screening. Participant must have home access to reliable and operational Wi-Fi and broadband internet at screening and throughout the study period. Participants/parents must have a device (mobile phone, tablet or computer) to record daily itch and sleep disturbance at screening and throughout the study period. Participant agrees to sleep by himself/herself (ie, with no other individuals or pets) in the monitored bedroom for the duration of the study (if not all times, at least 5 days a week for a minimum of 5 hours/night for a total of 16 weeks). Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age. Exclusion Criteria: - Known history of a childhood sleep disorder such as parasomnias (sleep walking, talking, terrors, etc.), behavioral insomnia of childhood, or restless leg syndrome. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subset of study-OBS15333 patients<br>As a sub-study of the OBS15333 pediatric AD registry (PEDISTAD), all participants in this study will be receiving standard care of therapies for moderate to severe AD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week -1 (baseline) to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week -1 (baseline) to week 12 |