Scratch Behavior Under Standard of Care
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      Wrist-worn accelerometers and associated data analysis platforms will provide quantitative
      and qualitative knowledge regarding the action of scratching and sleep quantity in a
      symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the
      sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC)
      quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current
      study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect
      significant and clinically meaningful changes in scratch behavior and sleep quantity in
      patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To
      evaluate this experimental paradigm, using wearable accelerometers, traditional
      patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal
      videography and physician assessments of AD will be assessed in a well-controlled
      observational methodology study that has both an in-patient and out-patient portions within
      the study.
    

Detailed description: 
      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.
    

Intervention name(s): Wrist Actigraphy Devices; Polysomnography; Videography
Intervention type(s): Device; Device; Device
Intervention description(s): A watch-like wearable sensor; Sleep Monitor; Thermal Camera
Other intervention name(s): GENEActiv Watch
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with atopic dermatitis
      
Keywords: Wearable devices; Scratch; Sleep