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Scratch Behavior Under Standard of Care (SOC)

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ClinicalTrials.gov Identifier: NCT03898427
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Kevin C.Thomas, Boston University

Tracking Information
First Submitted Date March 29, 2019
First Posted Date April 2, 2019
Last Update Posted Date March 26, 2020
Actual Study Start Date April 4, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2019)
  • Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments [ Time Frame: From enrollment through the end of visit 5 (15 days +/- 3 days). ]
    One GENEActiv watch will be used on each hand at a sampling rate of 100 Hz to measure movement in the x, y, and z direction. The movement will be analyzed using the algorithm described by Cole et al. to differentiate between periods of wakefulness and sleep following SOC treatments.
  • Quantification of sleep using polysomnography following SOC treatment [ Time Frame: From enrollment through the end of visit 5 (15 days +/- 3 days). ]
    Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging following SOC treatments based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals diagnosed with atopic dermatitis
Condition Atopic Dermatitis
Intervention
  • Device: Wrist Actigraphy Devices
    A watch-like wearable sensor
    Other Name: GENEActiv Watch
  • Device: Polysomnography
    Sleep Monitor
  • Device: Videography
    Thermal Camera
Study Groups/Cohorts Individuals with atopic dermatitis
Sensor technology and digital measures will be used to evaluate scratch and sleep in individuals with atopic dermatitis receiving standard of care treatments (SOC) who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography.
Interventions:
  • Device: Wrist Actigraphy Devices
  • Device: Polysomnography
  • Device: Videography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Riley Phelps, B.A. 617-358-9787 phelpsr@bu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03898427
Other Study ID Numbers H-38472
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kevin C.Thomas, Boston University
Study Sponsor Boston University
Collaborators Not Provided
Investigators
Principal Investigator: Kevin C Thomas, PhD, MBA Boston University, Department of Anatomy and Neurobiology
PRS Account Boston University
Verification Date March 2020