Atopic DermatitisSOCNCT03898427
Scratch Behavior Under Standard of Care
An observational study of Atopic Dermatitis, run by Boston University at 1 site in United States.
Trial summary
Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Wrist Actigraphy Devices, Polysomnography and Videography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 15 Dec 2020
- Phase
- Observational
- 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals diagnosed with atopic dermatitis
Who may be able to join
- Male or female subjects aged between ≥2 years of age and <75 years of age at Day 1.
- Written informed consent from subject/parent(s)/guardian(s) and assent from the subject, where assent is applicable (for those subjects under 18 years of age).
- Subject and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, and procedures.
- Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s) in the case of minors).
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.
Who cannot join
- Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at screening that precludes subject's participation in study activities.
- Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
- Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
- Has unstable AD (Total BSA>40%) (including a significant active systemic or localized infection).
Trial locations and contacts
1 site in 1 country.
United States1 site
Evans Biomedical Research Center
Boston, Massachusetts, 02118
About this study
Official title: Quantification of Improvement in Scratch Behavior and Sleep in Patients With Atopic Dermatitis on Standard of Care Treatment
Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.
Read the detailed description
This open label study is to evaluate the ability of a wrist-worn accelerometry device to detect scratch and sleep quantity changes in patients with Atopic Dermatitis (AD) receiving Standard of Care (SOC) treatment. Subjects, age 2 to 75 years, with symptomatic AD will be recruited.
The study will be comprised of an initial screening/baseline clinic visit when subject will be diagnosed with symptomatic AD, screened and enrolled in the study after signing an informed consent (or parents/guardians and assent when appropriate). The subject will start or modify a SOC treatment course at the physician's discretion, and thereafter will be followed up for a total of 2 weeks for the purposes of the study. During those 2 weeks, the subject will wear two wrist worn accelerometry devices. The subject will also have to complete daily PRO/ObsRO related to itch, sleeping habits, quality of life, and device comfort questionnaires (parent/guardian will complete as appropriate) and may also participate in an optional daily photography taken of a single lesion (optional and for adult subjects only 18-75 years of age). The subject will also be asked to come and stay overnight at the sleep clinic for an overnight between Days 1-3, for thermal video recording overnight. An optional additional night (immediately following the first clinic overnight; between days 2-4) with video and polysomnography (PSG) may occur (subjects must be 18-75 years of age to participate in this aspect of the study). The subjects will be asked to return to the clinic on days 8 and 15 for clinician-based assessments. At the completion of the study, Day 15 (+3 day) the subjects will return the devices, and will complete PRO/ObsRO questionnaires.
- Conditions
- Atopic Dermatitis
- Being tested
- Wrist Actigraphy Devices, Polysomnography, Videography
- Keywords
- Wearable devices, Scratch, Sleep
- 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 DevicesDevice
Also called GENEActiv Watch
A watch-like wearable sensor
PolysomnographyDevice
Sleep Monitor
VideographyDevice
Thermal Camera
| Study group | Role | What they receive |
|---|---|---|
| Individuals with atopic dermatitis | Sensor technology and digital measures will be used to evaluate scratch and sleep in individuals with atopic dermatitis receiving standard of care treatments (SOC) who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography. Receives: Device: Wrist Actigraphy Devices; Device: Polysomnography; Device: Videography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments
One GENEActiv watch will be used on each hand at a sampling rate of 100 Hz to measure movement in the x, y, and z direction. The movement will be analyzed using the algorithm described by Cole et al. to differentiate between periods of wakefulness and sleep following SOC treatments.
Measured: From enrollment through the end of visit 5 (15 days +/- 3 days).
Quantification of sleep using polysomnography following SOC treatment
Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging following SOC treatments based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).
Measured: From enrollment through the end of visit 5 (15 days +/- 3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start4 Apr 2019
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin C Thomas, PhD, MBA, Principal investigator, Boston University, Department of Anatomy and Neurobiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898427
- Sponsor's protocol ID
- H-38472
- Acronym
- SOC
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Improvement in Scratch Behavior and Sleep in Patients With Atopic Dermatitis on Standard of Care Treatment
- ClinicalTrials.gov ID
- NCT03898427
- Acronym / sponsor ID
- SOC / H-38472
- Conditions
- Atopic Dermatitis
- Keywords
- Wearable devices, Scratch, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 2 Apr 2019 (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.
Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.
Detailed description
This open label study is to evaluate the ability of a wrist-worn accelerometry device to detect scratch and sleep quantity changes in patients with Atopic Dermatitis (AD) receiving Standard of Care (SOC) treatment. Subjects, age 2 to 75 years, with symptomatic AD will be recruited.
The study will be comprised of an initial screening/baseline clinic visit when subject will be diagnosed with symptomatic AD, screened and enrolled in the study after signing an informed consent (or parents/guardians and assent when appropriate). The subject will start or modify a SOC treatment course at the physician's discretion, and thereafter will be followed up for a total of 2 weeks for the purposes of the study. During those 2 weeks, the subject will wear two wrist worn accelerometry devices. The subject will also have to complete daily PRO/ObsRO related to itch, sleeping habits, quality of life, and device comfort questionnaires (parent/guardian will complete as appropriate) and may also participate in an optional daily photography taken of a single lesion (optional and for adult subjects only 18-75 years of age). The subject will also be asked to come and stay overnight at the sleep clinic for an overnight between Days 1-3, for thermal video recording overnight. An optional additional night (immediately following the first clinic overnight; between days 2-4) with video and polysomnography (PSG) may occur (subjects must be 18-75 years of age to participate in this aspect of the study). The subjects will be asked to return to the clinic on days 8 and 15 for clinician-based assessments. At the completion of the study, Day 15 (+3 day) the subjects will return the devices, and will complete PRO/ObsRO questionnaires.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with atopic dermatitis | – | Device: Wrist Actigraphy Devices, Device: Polysomnography, Device: VideographySensor technology and digital measures will be used to evaluate scratch and sleep in individuals with atopic dermatitis receiving standard of care treatments (SOC) who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography. |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals diagnosed with atopic dermatitis
Key inclusion criteria (5 listed)
- Male or female subjects aged between ≥2 years of age and <75 years of age at Day 1.
- Written informed consent from subject/parent(s)/guardian(s) and assent from the subject, where assent is applicable (for those subjects under 18 years of age).
- Subject and parent(s)/guardian(s) are willing and able to comply with study instructions, study visits, and procedures.
- Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s) in the case of minors).
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka.
Key exclusion criteria (4 listed)
- Has any clinically significant medical disorder, condition, disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome) or clinically significant finding at screening that precludes subject's participation in study activities.
- Allergy to polyurethane resin (strap/wristband component), skin nickel allergy, silicone, and/or adhesives.
- Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
- Has unstable AD (Total BSA>40%) (including a significant active systemic or localized infection).
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 DevicesAlso: GENEActiv WatchA watch-like wearable sensor | Device | Individuals with atopic dermatitis |
| PolysomnographySleep Monitor | Device | Individuals with atopic dermatitis |
| VideographyThermal Camera | Device | Individuals with atopic dermatitis |
Primary outcome
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments
Time frame: From enrollment through the end of visit 5 (15 days +/- 3 days).
One GENEActiv watch will be used on each hand at a sampling rate of 100 Hz to measure movement in the x, y, and z direction. The movement will be analyzed using the algorithm described by Cole et al. to differentiate between periods of wakefulness and sleep following SOC treatments.
Quantification of sleep using polysomnography following SOC treatment
Time frame: From enrollment through the end of visit 5 (15 days +/- 3 days).
Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging following SOC treatments based on the scoring guide provided by the American Academy of Sleep Medicine (AASM). The following sleep stages will be scored: Stage W (wakefulness), Stage N1 (NREM 1), Stage N2 (NREM 2), Stage N3 (NREM 3), Stage N (NREM), and Stage R (REM).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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.
Kevin C Thomas, PhD, MBA principal investigator
Boston University, Department of Anatomy and Neurobiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Boston University at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry following standard of care (SOC) treatments (time frame: From enrollment through the end of visit 5 (15 days +/- 3 days).). The study lists 2 primary outcomes in all. 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 3 Mar 2021.