Status:
COMPLETED
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)
Lead Sponsor:
Sanofi
Conditions:
Dermatitis Atopic
Eligibility:
All Genders
6-11 years
Brief Summary
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...
Detailed Description
16 weeks
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 11 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05235724
Start Date
February 17 2022
End Date
January 11 2023
Last Update
January 31 2023
Active Locations (7)
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1
C2 Research Center, LLC-Site Number:8400071
Montgomery, Alabama, United States, 36117
2
Amedica Research Institute, Inc.-Site Number:8400067
Hialeah, Florida, United States, 33013
3
Eastern Research, Inc.-Site Number:8400032
Hialeah, Florida, United States, 33013
4
Skin Research of South Florida, LLC-Site Number:8400018
Miami, Florida, United States, 33173