Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05235724




Registration number
NCT05235724
Ethics application status
Date submitted
1/02/2022
Date registered
11/02/2022
Date last updated
31/01/2023

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
U1111-1269-6688
Secondary ID [2] 0 0
LPS17339
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Experimental: A, Treatment arm - Arm A: Participants scheduled for cochlear implantation and treated with oral 43.5 mg SENS-401 (R-Azasetron Besylate) twice daily for up to 49 days.

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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Correlation between weekly averages of Emerald nightly scratching events/hour and Emerald derived sleep efficiency
Timepoint [1] 0 0
Week -1 (baseline) to week 12
Secondary outcome [1] 0 0
Percentage (%) of nights with unusable data
Timepoint [1] 0 0
Week -1 (baseline) to week 12

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/01/2023
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT05235724
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05235724