Atopic Dermatitis With Accelerometry and Polysomnography (ADAP)
Condition: Atopic Dermatitis; Eczema; Healthy
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

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.
    

Intervention name(s): GENEActiv Accelerometry Device; Centrepoint Insights Watch (CPIW) Accelerometry Device; Apple Watch Accelerometry Device; Polysomnography; Videography
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): a watch like wearable sensor; a watch like wearable sensor; a watch like wearable sensor; Sleep monitor; Thermal Camera
Other intervention name(s): GENEActiv Watch; Centrepoint Insights Watch (CPIW); Apple Watch
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Participants over or including the age of 12 and under the age of 75 Participants
        with Atopic Dermatitis (AD) over or including the age of 12 and under the age of 75
      
Keywords: Atopic Dermatitis; Eczema; Healthy