Monitoring Of Scratch Via Accelerometry In Children (MOSAIC)

November 30, 2020 updated by: Boston University

Feasibility for Quantification of Scratch Behavior and Sleep in Children With Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Evans Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with atopic dermatitis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Wrist Actigraphy Devices
A watch-like wearable sensor
Other Names:
  • GENEActiv Watch
Device: Polysomnography
Sleep Monitor
Device: Videography
Thermal Camera
Device: Sleep Monitor
Remote Sensor
Other Names:
  • EarlySense

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry
Time Frame: From enrollment through the end of visit 5 (5 days +/- 2 days).
One GENEActiv watch will be used on each hand at a sampling rate of 100 Hz to measure movement in the x, y, and z direction. The movement will be analyzed using the algorithm described by Cole et al. to differentiate between periods of wakefulness and sleep.
From enrollment through the end of visit 5 (5 days +/- 2 days).
Quantification of sleep using Polysomnography
Time Frame: From enrollment through the end of visit 5 (5 days +/- 2 days).
Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging based on the scoring guide provided by the American Academy of Sleep Medicine (AASM) for children. The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).
From enrollment through the end of visit 5 (5 days +/- 2 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Investigators

  • Principal Investigator: Kevin C Thomas, PhD MBA, Boston University, Department of Anatomy and Neurobiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2018

Primary Completion (Actual)

June 9, 2020

Study Completion (Actual)

June 9, 2020

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-37801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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