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NCT06448689 Clinical Trial

Analytical Validation of Wrist-Based Assessment of Nocturnal Scratch in Atopic Dermatitis and Psoriasis

Psoriasis Clinical Trial

— DECODE-Scratch  

Official title:
Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06448689
Other study ID # AG0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 12, 2024
Est. completion date June 2026

Study information
Verified date June 2024
Source ActiGraph L.L.C
Contact Sylvain Zorman, PhD
Phone 850.332.7900
Email info@theactigraph.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date June 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 70 Years
Eligibility Inclusion criteria for participants with atopic dermatitis: - At least 14 years old - Less than 70 years old - Clinical diagnosis of Atopic Dermatitis - Peak Pruritis NRS score > 1 Inclusion criteria for participants with psoriasis: - At least 18 years old - Less than 70 years old - Clinical diagnosis of plaque psoriasis - At least a peak pruritis PNRS of 4 - Itch is caused by psoriasis, as determined by clinician Exclusion Criteria: - Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...) - Movement disorder - Flare or infection on the wrist - Infected atopic dermatitis or psoriasis lesions - Pregnant or lactating women - Shift workers or participants with jetlag - Current diagnosis of depression

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance Paris

Sponsors (1)
Lead Sponsor Collaborator
ActiGraph L.L.C

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Scratch Movements To evaluate the agreement in the detection of scratching behaviour between video annotation and wrist-based sensor 14 days
Primary Sleep Time To evaluate the agreement in the detection of sleep patterns between polysomnography and wrist-based sensor 14 days
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