NCT03873220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

1.5 years

First QC Date

March 11, 2019

Last Update Submit

November 30, 2020

Conditions

Atopic Dermatitis

Keywords

Wearable devicesScratchSleep

Outcome Measures

Primary Outcomes (2)

  • Quantification of scratch using GENEActiv watches to assess triaxial accelerometry

    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

    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).

Study Arms (1)

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 DevicesDevice: Sleep MonitorDevice: PolysomnographyDevice: Videography

Interventions

Wrist Actigraphy DevicesDEVICE

A watch-like wearable sensor

Also known as: GENEActiv Watch
Monitoring scratch in children
Sleep MonitorDEVICE

Remote Sensor

Also known as: EarlySense
Monitoring scratch in children
PolysomnographyDEVICE

Sleep Monitor

Monitoring scratch in children
VideographyDEVICE

Thermal Camera

Monitoring scratch in children

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with atopic dermatitis

You may qualify if:

  • Male or female subjects aged ≥2 years of age and \<12 years of age at Day 1.
  • Written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable).
  • Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s)).
  • Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evans Biomedical Research Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kevin C Thomas, PhD MBA

    Boston University, Department of Anatomy and Neurobiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

December 14, 2018

Primary Completion

June 9, 2020

Study Completion

June 9, 2020

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

US(1)