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Scratch Behavior Under Standard of Care

NCT03898427 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-03-03

No results posted yet for this study

Summary

Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.

Conditions

Interventions

DEVICE

Wrist Actigraphy Devices

A watch-like wearable sensor

DEVICE

Polysomnography

Sleep Monitor

DEVICE

Videography

Thermal Camera

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Kevin C Thomas, PhD, MBA · Boston University, Department of Anatomy and Neurobiology

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898427 on ClinicalTrials.gov