Clinical trial NCT03898427: Scratch Behavior Under Standard of Care
Official title: Quantification of Improvement in Scratch Behavior and Sleep in Patients With Atopic Dermatitis on Standard of Care Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Wearable devices
Scratch
Sleep
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with atopic dermatitis

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged between ≥2 years of age and \<75 years of age at Day 1.
2. Written informed consent from subject/parent(s)/guardian(s) and assent from the subject, where assent is applicable (for those subjects under 18 years of age).
3. Subject and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, and procedures.
4. Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s) in the case of minors).
5. Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.

Exclusion Criteria:

1. Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at screening that precludes subject's participation in study activities.
2. Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
3. Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
4. Has unstable AD (Total BSA\>40%) (including a significant active systemic or localized infection).

Primary outcomes:
measure: Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments
timeFrame: From enrollment through the end of visit 5 (15 days +/- 3 days).
measure: Quantification of sleep using polysomnography following SOC treatment
timeFrame: From enrollment through the end of visit 5 (15 days +/- 3 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Evans Biomedical Research Center
state: Massachusetts
Study officials:
affiliation: Boston University, Department of Anatomy and Neurobiology
name: Kevin C Thomas, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: