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

June 3, 2024 updated by: ActiGraph L.L.C

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75001
        • Recruiting
        • AP-HP, Hôtel-Dieu, Centre du Sommeil et de la Vigilance
        • Contact:
          • Damien Leger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ActiGraph L.L.C

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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