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)

Investigating Nighttime Scratching and Sleep Patterns in Children with Atopic Dermatitis

Not Recruiting
6 years - 11 years
All
Phase N/A
18 participants needed

Study Overview

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.

Study Details

16 weeks

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dermatitis Atopic
  • Age: 6 years - 11 years
  • Gender: All

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.

Updated on 31 Jan 2023. Study ID: NCT05235724

This study investigates the relationship between nighttime scratching and sleep patterns in children with moderate to severe atopic dermatitis, a skin condition that causes red, itchy rashes. The study will use an innovative tool called the Emerald touchless sensor to measure how scratching affects sleep.

Participants will use the Emerald sensor at home to track their sleep and scratching without needing to wear any devices. They will also use a mobile phone, tablet, or computer to record daily itch and sleep disturbances.

  • Who can participate: Children aged 6 to 11 years enrolled in the PEDISTAD registry in the US can participate. They must have moderate to severe atopic dermatitis, reliable internet access, and be able to sleep alone for most of the study period.
  • Study details: Participants will use a touchless sensor to monitor scratching and sleep patterns. They will need to record their itch levels and sleep disturbances daily using a device like a phone or tablet.
  • Study timelines: The study will last 16 weeks.