A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    56
  • sponsor
    AbbVie
Updated on 3 November 2021
sleep disturbances
atopy
eczema
scratch
Accepts healthy volunteers

Summary

Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients. This study aims to develop and validate a digital algorithm for accurately and reliably detecting and quantifying nocturnal scratch behaviors related to AD using wrist actigraphy data.

Wrist actigraphy is an investigational device being developed to detect and quantify scratching behaviors in patients with AD. This study will be conducted in 2 sequential stages: In Stage 1, an algorithm will be developed and in Stage 2 the algorithm developed will be validated. Adult healthy volunteers or participants with AD will be enrolled. Approximately 14 healthy volunteers, 14 AD patients with low disease activity and 28 AD patients with high disease activity will be enrolled in the study in 5 sites across the United States.

No drug will be administered as a part of this study.

Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. Participants will be enrolled and monitored overnight for two consecutive nights at an inpatient setting at a hospital or clinic. The impact of nocturnal scratching on sleep parameters will be assessed by videography, actigraphy, sleep headband and completing questionnaires.

Details
Condition Hand Dermatitis, Dermatitis, Eczema (Atopic Dermatitis), Eczema (Atopic Dermatitis - Pediatric), Dermatitis, Atopic, ATOPIC DERMATITIS, Atopic Dermatitis, Dermatite Atopique, Eczema, Eczéma (Dermatite Atopique)
Treatment Wrist Actigraphy Device, Sleep Headband
Clinical Study IdentifierNCT04262791
SponsorAbbVie
Last Modified on3 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Volunteers in general good health with no diagnosis of AD or any other dermatologic disorder that interferes with study assessments
For subjects with AD
Chronic AD with onset of symptoms at least 1 year prior to Day 1 and participant meets American Academy of Dermatology (AAD) criteria
Participant meets all of the following disease activity criteria
For AD subjects with high disease activity (AD-High)
Validated Investigator Global Assessment for AD (vIGA-AD) score >= 3 at the Screening and Day 1 visits
At least one of the following
Pruritus over the last 7 days (numerical rating scale 7-Day version [NRS-7]) >= 4 at the Screening and Day 1 visits
Eczema Area and Severity Index (EASI) score > 7 at the Screening and Day 1 visits; OR
For AD subjects with low disease activity (AD-Low)
vIGA-AD score >= 1 at the Screening and Day 1 visits
Pruritus over the last 7 days (NRS-7) >= 2 at the Screening and Day 1 visits
Does not meet AD-High criteria as described
Satisfy at least one of the following
EASI score >= 3 at the Screening and Day 1 visits OR

Exclusion Criteria

Significant eczema on wrists where devices will be worn that, in the opinion of the participant or investigator would likely lead to non-compliance
Interference (e.g., hairstyle) with the ability of Dreem 2 headband to collect sensor data
Unstable medical disorder or other condition that in the investigator's opinion may interfere with study procedures or study objectives
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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