Wrist-based assessment of nighttime scratching in skin conditions
Prospective, Hybrid, Single-Center, Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
This study is testing a new wrist device to see how much people with atopic dermatitis and psoriasis scratch at night and how it affects their sleep.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | ActiGraph L.L.C Industry-sponsored |
| Locations | 1 site (Paris) |
| Trial ID | NCT06448689 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a wrist-based solution for quantifying nocturnal scratching behaviors in patients with atopic dermatitis and psoriasis. By utilizing various technologies such as polysomnography, video capture, and wrist sensors, the study seeks to better understand the impact of pruritis on sleep quality and overall patient well-being. Participants will be monitored to assess their scratching behaviors and sleep disturbances, providing valuable data for improving treatment approaches.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14-70 with a clinical diagnosis of atopic dermatitis or individuals aged 18-70 with plaque psoriasis experiencing significant pruritis.
Not a fit: Patients with non-dermatological sleep disorders, movement disorders, or those currently experiencing flare-ups or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of nocturnal pruritis, enhancing the quality of life for patients with atopic dermatitis and psoriasis.
How similar studies have performed: While the approach of using wrist-based technology for monitoring nocturnal scratching is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance — Paris, France (Recruiting)
Study contacts
- Principal investigator: Damien Leger — Université Paris Cité, VIFASOM, ERC 7330, Paris, France;b AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance, Paris, France
- Study coordinator: Sylvain Zorman, PhD
- Email: info@theactigraph.com
- Phone: 850.332.7900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.