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

NCT04262791 | Terminated Phase 1 FDA Device

• 1 other identifier: F20-093
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Nocturnal Scratch Algorithm; Atopic Dermatitis (AD); Wrist Actigraphy

Outcome Measures

Primary Outcomes (1)

• Total Scratch Duration Per Night

  Total scratch duration per night (seconds/night) is measured by actigraphy and videography.

  Up to 10 Days

Secondary Outcomes (4)

• Number of Scratching Events

  Up to 10 Days

• Scratch Rate

  Up to 10 Days

• Scratch Duration

  Up to 10 Days

• Comparison of Actigraphy-Based Scratches to Videography-Based Scratches

  Up to 10 Days

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

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; Device: Sleep Headband

Participants With Atopic Dermatitis (AD)

EXPERIMENTAL

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; Device: Sleep Headband

Interventions

Wrist Actigraphy Device DEVICE

Wrist Actigraphy Device

Healthy Volunteers; Participants With Atopic Dermatitis (AD)

Sleep Headband DEVICE

Sleep Headband

Also known as: Dreem 2 Headband

Healthy Volunteers; Participants With Atopic Dermatitis (AD)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

PPD Clinical Research Unit /ID# 217010

Orlando, Florida, 32806-1044, United States

Location

Acpru /Id# 217345

Grayslake, Illinois, 60030, United States

Location

Univ Rochester Med Ctr /ID# 217490

Rochester, New York, 14620-2664, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 10, 2020
• Study Start: February 17, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)