Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
62 participants
OBSERVATIONAL
2018-12-14
2020-06-09
Brief Summary
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Detailed Description
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The study will be comprised of two overnight sleep laboratory site visits. The clinic visits will be followed by a continuous \~48 hour in-home environment assessment period (defined as the subject's daily routine environment). During the sleep lab site visit, the subject and accompanying parent(s)/guardian(s) will sleep overnight at the facility. The subject will be video-recorded during the in-sleep lab visit, wear the wrist accelerometry devices, use the sleep sensor and complete assessments (Depending on age, parent/guardian may complete some assessments). Upon the completion of sleep lab activities the subjects will then continue to wear the wrist accelerometry devices, utilize the sleep sensor and complete Patient Reported Outcome/Clinical Outcome Assessments (PRO/COA) assessments during the 48 hour in-home assessment. At the conclusion of the in-home portion of the assessment, the subject will return the device/s and assessments to the facility and undergo brief assessments/interview.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Monitoring scratch in children
Sensor technology and digital measures will be used to evaluate scratch and sleep in children with atopic dermatitis who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography.
Wrist Actigraphy Devices
A watch-like wearable sensor
Sleep Monitor
Remote Sensor
Polysomnography
Sleep Monitor
Videography
Thermal Camera
Interventions
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Wrist Actigraphy Devices
A watch-like wearable sensor
Sleep Monitor
Remote Sensor
Polysomnography
Sleep Monitor
Videography
Thermal Camera
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable).
3. Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s)).
4. Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
Exclusion Criteria
2. Has unstable AD (Total BSA\>40%).
3. Has any planned surgical or medical procedure that would overlap with study participation.
2 Years
11 Years
ALL
No
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Kevin C Thomas, PhD MBA
Role: PRINCIPAL_INVESTIGATOR
Boston University, Department of Anatomy and Neurobiology
Locations
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Evans Biomedical Research Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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H-37801
Identifier Type: -
Identifier Source: org_study_id