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Monitoring Of Scratch Via Accelerometry In Children (MOSAIC)

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ClinicalTrials.gov Identifier: NCT03873220
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin C.Thomas, Boston University

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.

Condition or disease Intervention/treatment
Atopic Dermatitis Device: Wrist Actigraphy Devices Device: Sleep Monitor Device: Polysomnography Device: Videography

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.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility for Quantification of Scratch Behavior and Sleep in Children With Atopic Dermatitis
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 Name: GENEActiv Watch

Device: Sleep Monitor
Remote Sensor
Other Name: EarlySense

Device: Polysomnography
Sleep Monitor

Device: Videography
Thermal Camera




Primary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with atopic dermatitis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873220


Contacts
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Contact: Riley Phelps, B.A 617-358-9787 phelpsr@bu.edu

Locations
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United States, Massachusetts
Evans Biomedical Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Riley Phelps, B.A.    617-358-9787    phelpsr@bu.edu   
Principal Investigator: Kevin C Thomas, PhD MBA         
Sponsors and Collaborators
Boston University
Investigators
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Principal Investigator: Kevin C Thomas, PhD MBA Boston University, Department of Anatomy and Neurobiology

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Responsible Party: Kevin C.Thomas, Assistant Professor, Anatomy & Neurobiology, Boston University
ClinicalTrials.gov Identifier: NCT03873220     History of Changes
Other Study ID Numbers: H-37801
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin C.Thomas, Boston University:
Wearable devices
Scratch
Sleep
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases