Back to resultsA Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Wrist Actigraphy Device
Sleep Headband
Sponsored by
About this trial
This is an interventional diagnostic trial for Atopic Dermatitis focused on measuring Nocturnal Scratch Algorithm, Atopic Dermatitis (AD), Wrist Actigraphy
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.
Sites / Locations
- PPD Clinical Research Unit /ID# 217010
- Acpru /Id# 217345
- Univ Rochester Med Ctr /ID# 217490
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Volunteers
Participants With Atopic Dermatitis (AD)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Total Scratch Duration Per Night
Total scratch duration per night (seconds/night) is measured by actigraphy and videography.
Secondary Outcome Measures
Number of Scratching Events
Number of scratching events are measured by actigraphy and videography
Scratch Rate
Scratch rate is measured by actigraphy.
Scratch Duration
Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04262791
Brief Title
A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)
Official Title
A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic Considerations
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Nocturnal Scratch Algorithm, Atopic Dermatitis (AD), Wrist Actigraphy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants With Atopic Dermatitis (AD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Wrist Actigraphy Device
Intervention Description
Wrist Actigraphy Device
Intervention Type
Device
Intervention Name(s)
Sleep Headband
Other Intervention Name(s)
Dreem 2 Headband
Intervention Description
Sleep Headband
Primary Outcome Measure Information:
Title
Total Scratch Duration Per Night
Description
Total scratch duration per night (seconds/night) is measured by actigraphy and videography.
Time Frame
Up to 10 Days
Secondary Outcome Measure Information:
Title
Number of Scratching Events
Description
Number of scratching events are measured by actigraphy and videography
Time Frame
Up to 10 Days
Title
Scratch Rate
Description
Scratch rate is measured by actigraphy.
Time Frame
Up to 10 Days
Title
Scratch Duration
Description
Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography
Time Frame
Up to 10 Days
Title
Comparison of Actigraphy-Based Scratches to Videography-Based Scratches
Description
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.
Time Frame
Up to 10 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
PPD Clinical Research Unit /ID# 217010
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1044
Country
United States
Facility Name
Acpru /Id# 217345
City
Grayslake
State/Province
Illinois
ZIP/Postal Code
60030
Country
United States
Facility Name
Univ Rochester Med Ctr /ID# 217490
City
Rochester
State/Province
New York
ZIP/Postal Code
14620-2664
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)
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