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

NCT ID: NCT04262791

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-17
• Study Completion Date: 2022-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wrist Actigraphy Device

Intervention Type: DEVICE

Wrist Actigraphy Device

Sleep Headband

Intervention Type: DEVICE

Sleep Headband

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.

Group Type: EXPERIMENTAL

Wrist Actigraphy Device

Intervention Type: DEVICE

Wrist Actigraphy Device

Sleep Headband

Intervention Type: DEVICE

Sleep Headband

Interventions

Wrist Actigraphy Device

Wrist Actigraphy Device

Intervention Type: DEVICE

Sleep Headband

Sleep Headband

Intervention Type: DEVICE

Other Intervention Names

Dreem 2 Headband

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

PPD Clinical Research Unit /ID# 217010

Orlando, Florida, United States

Acpru /Id# 217345

Grayslake, Illinois, United States

Univ Rochester Med Ctr /ID# 217490

Rochester, New York, United States

Countries

United States

Other Identifiers

F20-093

Identifier Type: -

Identifier Source: org_study_id