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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06448689

Acronym

DECODE-Scratch

Enrollment

Registered

2024-06-07

Start date

2024-03-12

Completion date

2026-06-30

Last updated

2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Psoriasis

Keywords

nocturnal scratch, itch, validation, sleep impairment, pruritis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactSylvain Zorman, PhD

info@theactigraph.com850.332.7900

Outcome results