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)

Dermatitis Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235724
• Other study ID #: LPS17339
• Secondary ID: U1111-1269-6688
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

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