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NCT03873220 · ClinicalTrials.gov registry record

Monitoring Of Scratch Via Accelerometry In Children

A clinical trial, sponsored by Boston University.

Completed
Registry status
62
Enrollment target

NCT03873220: Completed study, sponsored by Boston University.

NCT03873220 is a clinical trial that has completed, run by Boston University. The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03873220 has completed, sponsored by Boston University.

COMPLETED
Registry status
62 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DEVICE Videography
  • DEVICE Wrist Actigraphy Devices
  • DEVICE Polysomnography
  • DEVICE Sleep Monitor

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2018-12-14
Est. Completion 2020-06-09
Boston University

185 total trials

What the finished NCT03873220 record still lists

NCT03873220 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target.

The record links to 0 conditions, and to 4 interventions - of which Videography is the first listed.

NCT03873220 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03873220 about?

NCT03873220 is a clinical study titled "Monitoring Of Scratch Via Accelerometry In Children". 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 t...

What is the current status of trial NCT03873220?

This trial is currently completed. The enrollment target is 62 participants. The study started on 2018-12-14. Estimated completion is 2020-06-09.

What interventions are being tested in trial NCT03873220?

The interventions under investigation include: Videography (DEVICE), Wrist Actigraphy Devices (DEVICE), Polysomnography (DEVICE), Sleep Monitor (DEVICE).

Who is sponsoring clinical trial NCT03873220?

This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03873220, the US trial registry maintained by the National Library of Medicine. NCT03873220 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.