Scratch Behavior Under Standard of Care (SOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03898427|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment|
|Atopic Dermatitis||Device: Wrist Actigraphy Devices Device: Polysomnography Device: Videography|
This open label study is to evaluate the ability of a wrist-worn accelerometry device to detect scratch and sleep quantity changes in patients with Atopic Dermatitis (AD) receiving Standard of Care (SOC) treatment. Subjects, age 2 to 75 years, with symptomatic AD will be recruited.
The study will be comprised of an initial screening/baseline clinic visit when subject will be diagnosed with symptomatic AD, screened and enrolled in the study after signing an informed consent (or parents/guardians and assent when appropriate). The subject will start or modify a SOC treatment course at the physician's discretion, and thereafter will be followed up for a total of 2 weeks for the purposes of the study. During those 2 weeks, the subject will wear two wrist worn accelerometry devices. The subject will also have to complete daily PRO/ObsRO related to itch, sleeping habits, quality of life, and device comfort questionnaires (parent/guardian will complete as appropriate) and may also participate in an optional daily photography taken of a single lesion (optional and for adult subjects only 18-75 years of age). The subject will also be asked to come and stay overnight at the sleep clinic for an overnight between Days 1-3, for thermal video recording overnight. An optional additional night (immediately following the first clinic overnight; between days 2-4) with video and polysomnography (PSG) may occur (subjects must be 18-75 years of age to participate in this aspect of the study). The subjects will be asked to return to the clinic on days 8 and 15 for clinician-based assessments. At the completion of the study, Day 15 (+3 day) the subjects will return the devices, and will complete PRO/ObsRO questionnaires.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Quantification of Improvement in Scratch Behavior and Sleep in Patients With Atopic Dermatitis on Standard of Care Treatment|
|Actual Study Start Date :||April 4, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2022|
Individuals with atopic dermatitis
Sensor technology and digital measures will be used to evaluate scratch and sleep in individuals with atopic dermatitis receiving standard of care treatments (SOC) 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
- Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments [ Time Frame: From enrollment through the end of visit 5 (15 days +/- 3 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 following SOC treatments.
- Quantification of sleep using polysomnography following SOC treatment [ Time Frame: From enrollment through the end of visit 5 (15 days +/- 3 days). ]Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging following SOC treatments based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). 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): NCT03898427
|Contact: Riley Phelps, B.A.||firstname.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|