Clinical trial NCT05235724: 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)
Official title: Open-label 12-week Longitudinal Exploratory Study to Assess Reliability/Feasibility of Using Emerald Touchless Sensor for Scratching and Sleep Quantification in a Subset of PEDISTAD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only participants enrolled in the OBS15333 pediatric AD registry (PEDISTAD) in the United States (US) study sites will be allowed to participate in this study.

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 innovative Emerald touchless sensor.

Secondary objective: To evaluate the feasibility of using the Emerald touchless sensor in a pediatric clinical trial setting.

Detailed description: 16 weeks

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency
timeFrame: Week -1 (baseline) to week 12
Secondary outcomes:
measure: Percentage (%) of nights with unusable data
timeFrame: Week -1 (baseline) to week 12
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: C2 Research Center, LLC-Site Number:8400071
state: Alabama
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc.-Site Number:8400067
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.-Site Number:8400032
state: Florida
city: Miami
country: United States
facility: Skin Research of South Florida, LLC-Site Number:8400018
state: Florida
city: Waterford
country: United States
facility: Michigan Dermatology Institute-Site Number:8400059
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center-Site Number:8400017
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina-Site Number:8400013
state: South Carolina
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: