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

Last updated: June 3, 2024
Sponsor: ActiGraph L.L.C
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Eczema (Atopic Dermatitis - Pediatric)

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT06448689
AG0001
  • Ages 14-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleepapnea, 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

Total Participants: 90
Study Start date:
March 12, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance

    Paris, 75001
    France

    Active - Recruiting

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