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

NCT06448689 | Recruiting

• 1 other identifier: AG0001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Psoriasis

Keywords

nocturnal scratch; itch; validation; sleep impairment; pruritis

Outcome Measures

Primary Outcomes (2)

• Scratch Movements

  To evaluate the agreement in the detection of scratching behaviour between video annotation and wrist-based sensor

  14 days

• Sleep Time

  To evaluate the agreement in the detection of sleep patterns between polysomnography and wrist-based sensor

  14 days

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female subjects, aged 14-70 years old, with active atopic dermatitis or psoriasis

You may qualify if:

• At least 14 years old
• Less than 70 years old
• Clinical diagnosis of Atopic Dermatitis
• Peak Pruritis NRS score \> 1
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ActiGraph L.L.C: lead

Study Sites (1)

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

Paris, 75001, France

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Damien Leger

  Université Paris Cité, VIFASOM, ERC 7330, Paris, France;b AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Zorman, PhD

CONTACT

850.332.7900; info@theactigraph.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 7, 2024
• Study Start: March 12, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)