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

A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Device: Wrist Actigraphy Device; Device: Sleep Headband

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806-1044
      • PPD Clinical Research Unit /ID# 217010
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 217345
  • New York
    • Rochester, New York, United States, 14620-2664
      • Univ Rochester Med Ctr /ID# 217490

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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):

    • Pruritus over the last 7 days (numerical rating scale 7-Day version [NRS-7]) >= 4 at the Screening and Day 1 visits.

    • At least one of the following:

      • Eczema Area and Severity Index (EASI) score > 7 at the Screening and Day 1 visits; OR
      • Validated Investigator Global Assessment for AD (vIGA-AD) score >= 3 at the Screening and Day 1 visits;

  • For AD subjects with low disease activity (AD-Low):

    • 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
      • vIGA-AD score >= 1 at the Screening and Day 1 visits.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; Healthy participants will be monitored overnight for two consecutive nights at an inpatient setting to collect wrist actigraphy and videography data. Sleep headband (at sites where polysomnography (PSG) is available and performed) data will be collected on Night 2.	Device: Wrist Actigraphy Device; Wrist Actigraphy Device; Device: Sleep Headband; Sleep Headband; Other Names: Dreem 2 Headband
Experimental: Participants With Atopic Dermatitis (AD); Participants with AD will be monitored overnight for two consecutive nights at an inpatient setting to collect wrist actigraphy and videography data. Sleep headband (at sites where polysomnography (PSG) is available and performed) data will be collected on Night 2. Participants will also be monitored at home via wrist actigraphy, sleep headband when available in the outpatient setting for 7 consecutive nights.	Device: Wrist Actigraphy Device; Wrist Actigraphy Device; Device: Sleep Headband; Sleep Headband; Other Names: Dreem 2 Headband

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Scratch Duration Per Night	Total scratch duration per night (seconds/night) is measured by actigraphy and videography.	Up to 10 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Scratching Events	Number of scratching events are measured by actigraphy and videography	Up to 10 Days
Scratch Rate	Scratch rate is measured by actigraphy.	Up to 10 Days
Scratch Duration	Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography	Up to 10 Days
Comparison of Actigraphy-Based Scratches to Videography-Based Scratches	Actigraphy-based scratches, as determined by the final algorithm determined in Stage 1, will be compared to videography-based scratches over epoch in which scratch is scored by either actigraphy or videography (and ignoring epochs in which no scratch is scored by either method) over the sleep period.	Up to 10 Days

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Nocturnal Scratch Algorithm; Atopic Dermatitis (AD); Wrist Actigraphy
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: F20-093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No