NCT05583019

Atopic Dermatitis With Accelerometry and Polysomnography (ADAP)

Device Quantification of Scratch and Sleep in Atopic Dermatitis With Accelerometry and Polysomnography (ADAP) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 88 (actual)
• Sponsor: SymmetryScience Group, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to better understand how wrist-worn study devices that measure activity/motion ('accelerometry devices') can be used to assess scratching and sleep in participants aged 12-75 years, with and without Atopic Dermatitis (AD, eczema), in both a sleep laboratory (hotel) setting and in a daily life/home setting. In this study, we will be using three different wrist devices to collect information: an Apple Watch Series 7, an Actigraph CentrePoint Insights Watch (CPIW) and a GENEActiv Original Watch. We will also compare the movement and sleep measurements recorded on the devices to thermal video and sleep assessments done in the sleep laboratory (hotel) as well as compare them to Patient Reported Outcome (PRO) assessments.

Detailed description

The general procedures include an initial intake appointment on day 1 (can be completed up to 3 days prior in case of scheduling conflicts), two overnight sleep laboratory visits, followed by approximately 12 days of wearing the devices during the participant's normal day-to-day activities and answering questions on a study-provided iPhone in the routine/home setting. The participant will be asked to complete questionnaires related to itch, sleep, pain, and overall Atopic Dermatitis (AD) severity each day, as relevant, and continuously wear wrist-worn accelerometry devices (as specified) during the study. The study will begin with an initial in-laboratory intake appointment to verify study eligibility to participate in the study. We do our best to screen for study eligibility over the phone, but there are some eligibility requirements that must be assessed in person. This means that at the first appointment, there is a chance that the prospective participant will not be eligible to continue with the remainder of study activities. In the event that they are not eligible to continue at the first in- person appointment, they will be compensated a prorated study amount for their time. Following the initial intake appointment, the participant will sleep overnight at the sleep laboratory/hotel. The participant will wear both the Apple Watch and the CentrePoint Insights Watch (CPIW) wrist devices, one of each, on both wrists. They will be asked to don the devices at least 6 hours before bedtime on the first overnight visit (day 1) and wear devices continuously (as specified) thereafter. The participant will be video recorded with an infra-red thermal camera (this video is de-identified, and only shows a heat map of their body, so facial features cannot be seen) during the sleep laboratory/hotel visits, wear the wrist accelerometry devices, and complete electronic questionnaires. In addition, on the second overnight in the sleep lab they will also have sensors placed on their head and limbs to monitor their sleep. Both nights, all three devices will also be next to the participant on the night stand, collecting information about their surroundings while they sleep. Upon the completion of the second night in the sleep laboratory (Days 1 and 2), they will then continue to wear wrist accelerometry devices and complete Patient Reported Outcome (PRO) questionnaires at home. The participants will be split into two cohorts (groups): Cohort 1 will wear both the CPIW and the GENEActiv device on both wrists and Cohort 2 will wear both the Apple Watch and GENEActiv device on both wrists. The participants will return to the laboratory on day 8 (+/- 2 days) to swap out devices. Cohort 1 will then wear both the Apple Watch and the GENEActiv device on both wrists and Cohort 2 will wear both the CPIW and GENEActiv device on both wrists for the remaining study days. At the conclusion of the at-home portion of the study, the participant will return the devices and assessments to the laboratory and complete final assessments.

Conditions

• Atopic Dermatitis
• Eczema
• Healthy

Interventions

Type	Name	Description
DEVICE	GENEActiv Accelerometry Device	a watch like wearable sensor
DEVICE	Centrepoint Insights Watch (CPIW) Accelerometry Device	a watch like wearable sensor
DEVICE	Apple Watch Accelerometry Device	a watch like wearable sensor
DEVICE	Polysomnography	Sleep monitor
DEVICE	Videography	Thermal Camera

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-05-11
• Completion: 2023-05-11
• First posted: 2022-10-17
• Last updated: 2023-08-15

Locations

1 site across 1 country: United States