Atopic DermatitisPhase 1NCT04262791
A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)
A Phase 1 study testing Wrist Actigraphy Device and Sleep Headband in people with Atopic Dermatitis, run by AbbVie at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Wrist Actigraphy Device and Sleep Headband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Feb 2020to 31 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Acpru /Id# 217345
Grayslake, Illinois, 60030
PPD Clinical Research Unit /ID# 217010
Orlando, Florida, 32806-1044
Univ Rochester Med Ctr /ID# 217490
Rochester, New York, 14620-2664
About this study
Official title: A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs
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.
Read more
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
- Being tested
- Wrist Actigraphy Device, Sleep Headband
- Keywords
- Nocturnal Scratch Algorithm, Atopic Dermatitis (AD), Wrist Actigraphy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist Actigraphy DeviceDevice
Wrist Actigraphy Device
Sleep HeadbandDevice
Also called Dreem 2 Headband
Sleep Headband
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Wrist Actigraphy Device; Device: Sleep Headband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Scratch Duration Per Night
Total scratch duration per night (seconds/night) is measured by actigraphy and videography.
Measured: Up to 10 Days
Secondary outcomes (4)
Number of Scratching Events
Number of scratching events are measured by actigraphy and videography
Measured: Up to 10 Days
Scratch Rate
Scratch rate is measured by actigraphy.
Measured: Up to 10 Days
Scratch Duration
Scratch duration is defined as percentage of total rest/sleep time as measured by actigraphy and videography
Measured: Up to 10 Days
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.
Measured: Up to 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start17 Feb 2020
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Why it stopped: Strategic Considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262791
- Sponsor's protocol ID
- F20-093
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs
- ClinicalTrials.gov ID
- NCT04262791
- Acronym / sponsor ID
- F20-093
- Conditions
- Atopic Dermatitis
- Keywords
- Nocturnal Scratch Algorithm, Atopic Dermatitis (AD), Wrist Actigraphy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic Considerations
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Wrist Actigraphy Device, Device: Sleep HeadbandHealthy 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 Atopic Dermatitis (AD) | Experimental | Device: Wrist Actigraphy Device, Device: Sleep HeadbandParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist Actigraphy DeviceWrist Actigraphy Device | Device | Healthy Volunteers, Participants With Atopic Dermatitis (AD) |
| Sleep HeadbandAlso: Dreem 2 HeadbandSleep Headband | Device | Healthy Volunteers, Participants With Atopic Dermatitis (AD) |
Primary outcome
Total Scratch Duration Per Night
Time frame: Up to 10 Days
Total scratch duration per night (seconds/night) is measured by actigraphy and videography.
4 secondary outcomes
Number of Scratching Events
Time frame: Up to 10 Days
Scratch Rate
Time frame: Up to 10 Days
Scratch Duration
Time frame: Up to 10 Days
Comparison of Actigraphy-Based Scratches to Videography-Based Scratches
Time frame: Up to 10 Days
Results and safety
The study was stopped early (reason given: Strategic Considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wrist Actigraphy Device and Sleep Headband in people with Atopic Dermatitis, run by AbbVie at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic Considerations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Scratch Duration Per Night (time frame: Up to 10 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.