Monitoring Of Scratch Via Accelerometry In Children
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 2 - 11 |
| Updated: | 3/15/2019 |
| Start Date: | December 14, 2018 |
| End Date: | December 2019 |
| Contact: | Riley Phelps, B.A |
| Email: | phelpsr@bu.edu |
| Phone: | 617-358-9787 |
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.
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.
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.
(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.
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.
We found this trial at
1
site
650 Albany Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Principal Investigator: Kevin C Thomas, PhD MBA
Phone: 617-358-9787
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