Clinical trial NCT03873220: Monitoring Of Scratch Via Accelerometry In Children
Official title: Feasibility for Quantification of Scratch Behavior and Sleep in Children With Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Wearable devices
Scratch
Sleep
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 62
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with atopic dermatitis

Brief summary: 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.

Detailed description: To assess the feasibility of quantifying scratch and sleep in children with Atopic Dermatitis (AD), children, age 2 to 11 years, with AD will be recruited. The subjects will complete specific questionnaires related to itch, sleeping habits and AD and continuously wear two wrist worn accelerometry devices. The EarlySense Sleep Monitor will also be placed underneath the mattress to measure additional sleep related activities.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged ≥2 years of age and \<12 years of age at Day 1.
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:

1. AD affected surface areas are in a location of device placement.
2. Has unstable AD (Total BSA\>40%).
3. Has any planned surgical or medical procedure that would overlap with study participation.

Primary outcomes:
measure: Quantification of scratch using GENEActiv watches to assess triaxial accelerometry
timeFrame: From enrollment through the end of visit 5 (5 days +/- 2 days).
measure: Quantification of sleep using Polysomnography
timeFrame: From enrollment through the end of visit 5 (5 days +/- 2 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Evans Biomedical Research Center
state: Massachusetts
Study officials:
affiliation: Boston University, Department of Anatomy and Neurobiology
name: Kevin C Thomas, PhD MBA
role: PRINCIPAL_INVESTIGATOR
References: