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)
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
2 other identifiers
observational
18
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2022
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
February 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2023
CompletedJanuary 31, 2023
January 1, 2023
11 months
February 1, 2022
January 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage (%) of nights with unusable data
Week -1 (baseline) to week 12
Study Arms (1)
Subset of study-OBS15333 patients
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.
Eligibility Criteria
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.
You may qualify 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 qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (7)
C2 Research Center, LLC-Site Number:8400071
Montgomery, Alabama, 36117, United States
Amedica Research Institute, Inc.-Site Number:8400067
Hialeah, Florida, 33013, United States
Eastern Research, Inc.-Site Number:8400032
Hialeah, Florida, 33013, United States
Skin Research of South Florida, LLC-Site Number:8400018
Miami, Florida, 33173, United States
Michigan Dermatology Institute-Site Number:8400059
Waterford, Michigan, 48328, United States
Cincinnati Children's Hospital Medical Center-Site Number:8400017
Cincinnati, Ohio, 45229, United States
Medical University of South Carolina-Site Number:8400013
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2022
First Posted
February 11, 2022
Study Start
February 17, 2022
Primary Completion
January 11, 2023
Study Completion
January 11, 2023
Last Updated
January 31, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org