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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04262791
• Other study ID #: F20-093
• Status: Terminated
• Phase: Phase 1
• Start date: February 17, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Wrist Actigraphy Device
Wrist Actigraphy Device
• Sleep Headband
Sleep Headband

Locations

Country	Name	City	State
United States	Acpru /Id# 217345	Grayslake	Illinois
United States	PPD Clinical Research Unit /ID# 217010	Orlando	Florida
United States	Univ Rochester Med Ctr /ID# 217490	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Scratch Duration Per Night	Total scratch duration per night (seconds/night) is measured by actigraphy and videography.	Up to 10 Days
Secondary	Number of Scratching Events	Number of scratching events are measured by actigraphy and videography	Up to 10 Days
Secondary	Scratch Rate	Scratch rate is measured by actigraphy.	Up to 10 Days
Secondary	Scratch Duration	Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography	Up to 10 Days
Secondary	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