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Trial record 3 of 7 for:    dreem

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262791
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 2-3 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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: Wrist Actigraphy Device Device: Sleep Headband Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs
Actual Study Start Date : February 17, 2020
Estimated Primary Completion Date : November 27, 2020
Estimated Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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 Name: 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 Name: Dreem 2 Headband




Primary Outcome Measures :
  1. Total Scratch Duration Per Night [ Time Frame: Up to 10 Days ]
    Total scratch duration per night (seconds/night) is measured by actigraphy and videography.


Secondary Outcome Measures :
  1. Number of Scratching Events [ Time Frame: Up to 10 Days ]
    Number of scratching events are measured by actigraphy and videography

  2. Scratch Rate [ Time Frame: Up to 10 Days ]
    Scratch rate is measured by actigraphy.

  3. Scratch Duration [ Time Frame: Up to 10 Days ]
    Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography

  4. Comparison of Actigraphy-Based Scratches to Videography-Based Scratches [ Time Frame: Up to 10 Days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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):

        1. Eczema Area and Severity Index (EASI) score >= 16 at the Screening and Day 1 visits;
        2. Validated Investigator Global Assessment for AD (vIGA-AD) score >= 3 at the Screening and Day 1 visits;
        3. Pruritus over the last 7 days (numerical rating scale 7-Day version [NRS-7]) >= 4 at the Screening and Day 1 visits.
      • For AD subjects with low disease activity (AD-Low):

        1. EASI score >= 7 at the Screening and Day 1 visits;
        2. vIGA-AD score >= 1 at the Screening and Day 1 visits;
        3. Pruritus over the last 7 days (NRS-7) >= 2 at the Screening and Day 1 visits.
        4. Does not meet AD-High criteria as described.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262791


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Florida
Ppd /Id# 217010 Not yet recruiting
Orlando, Florida, United States, 32806-1044
United States, Illinois
Acpru /Id# 217345 Recruiting
Grayslake, Illinois, United States, 60030
United States, New York
Univ Rochester Med Ctr /ID# 217490 Not yet recruiting
Rochester, New York, United States, 14642
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04262791    
Other Study ID Numbers: F20-093
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by AbbVie:
Nocturnal Scratch Algorithm
Atopic Dermatitis (AD)
Wrist Actigraphy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases