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)

Sanofi

Status: Completed

Conditions: Dermatitis Atopic

Study type: Observational

Funder types: Industry

Identifiers

NCT05235724

LPS17339

U1111-1269-6688 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

16 weeks

Enrollment: 18 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

18 participants in 1 patient group

Subset of study-OBS15333 patients

Description:

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.