Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients. This study aims to develop and validate a digital algorithm for accurately and reliably detecting and quantifying nocturnal scratch behaviors related to AD using wrist actigraphy data. Wrist actigraphy is an investigational device being developed to detect and quantify scratching behaviors in patients with AD. This study will be conducted in 2 sequential stages: In Stage 1, an algorithm will be developed and in Stage 2 the algorithm developed will be validated. Adult healthy volunteers or participants with AD will be enrolled. Approximately 14 healthy volunteers, 14 AD patients with low disease activity and 28 AD patients with high disease activity will be enrolled in the study in 5 sites across the United States. No drug will be administered as a part of this study. Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. Participants will be enrolled and monitored overnight for two consecutive nights at an inpatient setting at a hospital or clinic. The impact of nocturnal scratching on sleep parameters will be assessed by videography, actigraphy, sleep headband and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Wrist Actigraphy Device
Sleep Headband
PPD Clinical Research Unit /ID# 217010
Orlando, Florida, United States
Acpru /Id# 217345
Grayslake, Illinois, United States
Univ Rochester Med Ctr /ID# 217490
Rochester, New York, United States
Total Scratch Duration Per Night
Total scratch duration per night (seconds/night) is measured by actigraphy and videography.
Time frame: Up to 10 Days
Number of Scratching Events
Number of scratching events are measured by actigraphy and videography
Time frame: Up to 10 Days
Scratch Rate
Scratch rate is measured by actigraphy.
Time frame: Up to 10 Days
Scratch Duration
Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography
Time frame: Up to 10 Days
Comparison of Actigraphy-Based Scratches to Videography-Based Scratches
Actigraphy-based scratches, as determined by the final algorithm determined in Stage 1, will be compared to videography-based scratches over epoch in which scratch is scored by either actigraphy or videography (and ignoring epochs in which no scratch is scored by either method) over the sleep period.
Time frame: Up to 10 Days
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