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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
16 weeks
Age
6–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | 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)
