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)

Completed

Conditions studied: Dermatitis Atopic

In brief

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.

Key facts

Study ID

NCT05235724

Run by

Sanofi

People needed

18

Starts

2022-02-17

Expected to finish

2023-01-11

Last updated by the study team

2023-01-31

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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