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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05235724
Other study ID # LPS17339
Secondary ID U1111-1269-6688
Status Completed
Phase
First received
Last updated
Start date February 17, 2022
Est. completion date January 11, 2023

Study information

Verified date January 2023
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

16 weeks


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date January 11, 2023
Est. primary completion date January 11, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 11 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Medical University of South Carolina-Site Number:8400013 Charleston South Carolina
United States Cincinnati Children's Hospital Medical Center-Site Number:8400017 Cincinnati Ohio
United States Amedica Research Institute, Inc.-Site Number:8400067 Hialeah Florida
United States Eastern Research, Inc.-Site Number:8400032 Hialeah Florida
United States Skin Research of South Florida, LLC-Site Number:8400018 Miami Florida
United States C2 Research Center, LLC-Site Number:8400071 Montgomery Alabama
United States Michigan Dermatology Institute-Site Number:8400059 Waterford Michigan

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency Total no. of scratching events and scratching duration within each sleep stage each night will be calculated. Sleep efficiency: total time spent in a sleep stage (Stage 2, 3 or Rapid Eye Movement (REM) stage) relative to the total time in bed will be expressed as a %. Total time in bed: time from when the person enters the bed area and they become relatively static to waking up for the day. Correlation coefficient will be derived using data pairs from baseline through 12 weeks using evaluable data. Week -1 (baseline) to week 12
Secondary Percentage (%) of nights with unusable data The weekly average values (both baseline and post baseline, Emerald and participant reported) will be considered evaluable if they are based on at least 3 evaluable nightly values. Nights with unusable Emerald data are defined as nights with no data being collected by the device for any reason or the data collected were unevaluable. Week -1 (baseline) to week 12
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