Scratching Validation Study

Independent Validation Study of Nighttime Scratching Quantification With Actigraphy in Adults With Atopic Dermatitis

Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Device: Actigraphy Device

Detailed Description

The Philips scratching algorithm has been cross-validated against the gold-standard assessment of scratching. The algorithm has been used in many drug development trials, occasionally as a means of generating secondary endpoints, but most often as a means of generating exploratory endpoints. The purpose of the proposed study is therefore to validate the data generated by the scratching study compared to the gold-standard video-assessment of scratching, in an independent sample of adults with atopic dermatitis and age- and sex-matched controls

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Maplewood, Missouri, United States, 63143
      • Clayton Sleep Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy & Atopic dermatitis subjects

Description

Inclusion Criteria:

• Be aged 18 to 75 years, inclusive
• Be willing and able to undergo a single night of actigraphy and video monitoring overnight in a laboratory
• Be willing and able to provide informed consent
• (patients only): Diagnosed with atopic dermatitis by a clinician, following the criteria listed in Table 1.
• (patients only): IGA score ≥ 2.
• (patients only): Willing and able to use only non-medicated topical therapy (i.e., bland emollient/moisturizer) for 7 days before the overnight visit.
• Participants should be in bed a minimum of 4 hours

Exclusion Criteria:

• Any acute and/or unstable illness or medical complication which, in the opinion of a clinician, could compromise data collection and/or interpretation
• Use of any over-the-counter, prescription, or recreational drugs that may induce sleep or pruritus within 24 hours prior to overnight monitoring

• Use of any over-the-counter or prescription treatment (systemic, or topical) that could affect the course of atopic dermatitis during the study period. Key medications are listed below:

  • From 3 Months prior to overnight visit: Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor inhibitors, antiimmunoglobulin IgE antibodies, anti-CD20 antibodies, anti-interleukin-4 receptor)
  • Has used systemic treatments that could affect AD within 30 days or 5 half- lives before the overnight visit. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and systemic corticosteroids)
  • Phototherapy treatment, laser therapy, bleach baths, tanning booths or extended sun exposure that could affect disease severity or interfere with disease assessments within 30 days before the overnight visit.
  • Use within 21 days before the overnight visit: Topical corticosteroids that were classified as super-high potency (clobetasol propionate).
  • Use within 14 days before the overnight visit: any other topical phosphodiesterase 4 (PDE4) inhibitor; Tacrolimus and pimecrolimus cream and/or ointment; Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone).

  • From 7 days before the overnight visit:

    • antibiotics
    • antifungal or antivirus medications
    • Antihistamines/anti-allergics: diphenhydramine, chlorpheniramine maleate, hydroxyzine)
    • Topical phosphodiesterase 4 (PDE4) inhibitor
    • Topical calcineurin inhibitors (tacrolimus and pimecrolimus cream and/or ointment)
    • Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone)
    • Any other topical therapy with active ingredients to treat AD or with additives that could affect AD (e.g., hyaluronic acid, urea, ceramide or filaggrin degradation products).
• Individuals clinically diagnosed with a sleep disorder who are NOT on a controlled treatment regime
• An Epworth Sleepiness Scale score of ≥11, indicating daytime hypersomnolence
• Previous diagnosis of a movement disorder, including but not limited to, restless legs syndrome, periodic limb movement disorder, Tourette's syndrome, tremor, or dystonia
• Commercial driver's license and/or high-risk occupation that could be impacted by the occurrence of daytime sleepiness
• Self-reported habitual sleep duration of <6 hours per night on average
• Shift worker, advanced/delayed circadian phase, and/or any other condition suggesting that the participant would be unable to sleep during overnight monitoring
• Self-reported pregnancy current or planned during the study
• Employee or spouse of an employee of company that designs, sells, or manufactures sleep related products and/or wearable devices (including Philips).
• (patients only): Any significant dermatological condition, other than atopic dermatitis, as determined by a clinician.
• (controls only): Any significant dermatological condition as determined by a clinician.
• Currently using medication for any skin disease/condition and could not, in the opinion of the investigator, tolerate restriction or discontinuation of the medication as required by the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	Device: Actigraphy Device; Patients will wear actigraphy device which detects scratching events.
Atopic dermatitis	Device: Actigraphy Device; Patients will wear actigraphy device which detects scratching events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and precision of the scratching algorithm with reference to the gold standard.	Assessment of the performance of the scratching algorithm as detected by actigraphy compared to infra red video monitoring.	Through study completion, analyst review following each patient's overnight intervention/session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement via additional performance metrics between the scratching algorithm and the gold standard.	Overall agreement of algorithm-determined scratching events and total duration compared to video scoring of scratching events; Other performance metrics such as Cohen's kappa and correlation between the number and duration of scratching events detected by the scratching algorithm versus video scoring	Through study completion, analyst review following each patient's overnight intervention/session

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Scratching
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: SRC_NBS_GENEActiv_2019_10763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No