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)

January 16, 2023 updated by: Sanofi

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

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 Overview

Status

Recruiting

Conditions

Detailed Description

16 weeks

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36117
        • Recruiting
        • C2 Research Center, LLC-Site Number:8400071
    • Florida
      • Hialeah, Florida, United States, 33013
        • Active, not recruiting
        • Eastern Research, Inc.-Site Number:8400032
      • Hialeah, Florida, United States, 33013
        • Completed
        • Amedica Research Institute, Inc.-Site Number:8400067
      • Miami, Florida, United States, 33173
        • Recruiting
        • Skin Research of South Florida, LLC-Site Number:8400018
    • Michigan
      • Waterford, Michigan, United States, 48328
        • Completed
        • Michigan Dermatology Institute-Site Number:8400059
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Active, not recruiting
        • Cincinnati Children's Hospital Medical Center-Site Number:8400017
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Completed
        • Medical University of South Carolina-Site Number:8400013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency
Time Frame: Week -1 (baseline) to week 12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage (%) of nights with unusable data
Time Frame: Week -1 (baseline) to week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2022

Primary Completion (Anticipated)

January 16, 2023

Study Completion (Anticipated)

January 16, 2023

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 16, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS17339
  • U1111-1269-6688 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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