Scratching Validation Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy subjects Healthy subjects |
Device: Actigraphy Device
Patients will wear actigraphy device which detects scratching events.
|
| Atopic dermatitis Atopic dermatitis |
Device: Actigraphy Device
Patients will wear actigraphy device which detects scratching events.
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and precision of the scratching algorithm with reference to the gold standard. [Through study completion, analyst review following each patient's overnight intervention/session]
Assessment of the performance of the scratching algorithm as detected by actigraphy compared to infra red video monitoring.
Secondary Outcome Measures
- Agreement via additional performance metrics between the scratching algorithm and the gold standard. [Through study completion, analyst review following each patient's overnight intervention/session]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be aged 18 to 75 years, inclusive
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Be willing and able to undergo a single night of actigraphy and video monitoring overnight in a laboratory
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Be willing and able to provide informed consent
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(patients only): Diagnosed with atopic dermatitis by a clinician, following the criteria listed in Table 1.
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(patients only): IGA score ≥ 2.
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(patients only): Willing and able to use only non-medicated topical therapy (i.e., bland emollient/moisturizer) for 7 days before the overnight visit.
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Participants should be in bed a minimum of 4 hours
Exclusion Criteria:
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Any acute and/or unstable illness or medical complication which, in the opinion of a clinician, could compromise data collection and/or interpretation
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Use of any over-the-counter, prescription, or recreational drugs that may induce sleep or pruritus within 24 hours prior to overnight monitoring
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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:
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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)
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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)
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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.
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Use within 21 days before the overnight visit: Topical corticosteroids that were classified as super-high potency (clobetasol propionate).
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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).
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From 7 days before the overnight visit:
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antibiotics
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antifungal or antivirus medications
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Antihistamines/anti-allergics: diphenhydramine, chlorpheniramine maleate, hydroxyzine)
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Topical phosphodiesterase 4 (PDE4) inhibitor
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Topical calcineurin inhibitors (tacrolimus and pimecrolimus cream and/or ointment)
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Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone)
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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).
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Individuals clinically diagnosed with a sleep disorder who are NOT on a controlled treatment regime
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An Epworth Sleepiness Scale score of ≥11, indicating daytime hypersomnolence
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Previous diagnosis of a movement disorder, including but not limited to, restless legs syndrome, periodic limb movement disorder, Tourette's syndrome, tremor, or dystonia
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Commercial driver's license and/or high-risk occupation that could be impacted by the occurrence of daytime sleepiness
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Self-reported habitual sleep duration of <6 hours per night on average
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Shift worker, advanced/delayed circadian phase, and/or any other condition suggesting that the participant would be unable to sleep during overnight monitoring
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Self-reported pregnancy current or planned during the study
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Employee or spouse of an employee of company that designs, sells, or manufactures sleep related products and/or wearable devices (including Philips).
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(patients only): Any significant dermatological condition, other than atopic dermatitis, as determined by a clinician.
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(controls only): Any significant dermatological condition as determined by a clinician.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clayton Sleep Institute | Maplewood | Missouri | United States | 63143 |
Sponsors and Collaborators
- Philips Clinical & Medical Affairs Global
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SRC_NBS_GENEActiv_2019_10763