Monitoring Of Scratch Via Accelerometry In Children
Completed
Conditions studied: Atopic Dermatitis
In brief
Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. The overall aim of this research is to validate the use of sensor technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients, and specifically in this study in children ages 2 to 11 years. To evaluate this experimental paradigm, the investigators propose using wearable accelerometers, a sleep sensor, PSG, videography and associated traditional patient-reported outcome measures/clinical outcome assessments (PRO/COA) in patients/caregivers with AD in a well-controlled in-laboratory and at-home study.
Key facts
- Study ID
- NCT03873220
- Run by
- Boston University
- People needed
- 62
- Starts
- 2018-12-14
- Expected to finish
- 2020-06-09
- Last updated by the study team
- 2020-12-01
Who can join
Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects aged ≥2 years of age and <12 years of age at Day 1.
- Written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable).
- Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s)).
- Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
You may not qualify if…
- AD affected surface areas are in a location of device placement.
- Has unstable AD (Total BSA>40%).
- Has any planned surgical or medical procedure that would overlap with study participation.
Where it is running
- Evans Biomedical Research Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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