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
|Condition or disease||Intervention/treatment|
|Atopic Dermatitis||Device: Wrist Actigraphy Devices Device: Sleep Monitor Device: Polysomnography Device: Videography|
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|
|Estimated Enrollment :||50 participants|
|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|
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
Other Name: EarlySense
- 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.
- 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).
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
|Contact: Riley Phelps, B.Afirstname.lastname@example.org|
|United States, Massachusetts|
|Evans Biomedical Research Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Riley Phelps, B.A. 617-358-9787 email@example.com|
|Principal Investigator: Kevin C Thomas, PhD MBA|
|Principal Investigator:||Kevin C Thomas, PhD MBA||Boston University, Department of Anatomy and Neurobiology|