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

NCT ID: NCT06448689

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-12

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ActiGraph L.L.C

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Damien Leger

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sylvain Zorman, PhD

Role: CONTACT

850.332.7900

Facility Contacts

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Damien Leger, MD

Role: primary

Other Identifiers

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AG0001

Identifier Type: -

Identifier Source: org_study_id

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