Atopic DermatitisMOSAICNCT03873220
Monitoring Of Scratch Via Accelerometry In Children
An observational study of Atopic Dermatitis, run by Boston University at 1 site in United States.
Trial summary
Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis platforms would 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 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Wrist Actigraphy Devices, Sleep Monitor and Polysomnography
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2018to 9 Jun 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 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Individuals diagnosed with atopic dermatitis
Who may be able to join
- Male or female subjects aged ≥2 years of age and <12 years of age at Day 1.
- Written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable).
- Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s)).
- Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
Who cannot join
- AD affected surface areas are in a location of device placement.
- Has unstable AD (Total BSA>40%).
- Has any planned surgical or medical procedure that would overlap with study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Evans Biomedical Research Center
Boston, Massachusetts, 02118
About this study
Official title: Feasibility for Quantification of Scratch Behavior and Sleep in Children With Atopic Dermatitis
Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. The overall aim of this research is to validate the use of sensor technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients, and specifically in this study in children ages 2 to 11 years. To evaluate this experimental paradigm, the investigators propose using wearable accelerometers, a sleep sensor, PSG, videography and associated traditional patient-reported outcome measures/clinical outcome assessments (PRO/COA) in patients/caregivers with AD in a well-controlled in-laboratory and at-home study.
Read the detailed description
To assess the feasibility of quantifying scratch and sleep in children with Atopic Dermatitis (AD), children, age 2 to 11 years, with AD will be recruited. The subjects will complete specific questionnaires related to itch, sleeping habits and AD and continuously wear two wrist worn accelerometry devices. The EarlySense Sleep Monitor will also be placed underneath the mattress to measure additional sleep related activities.
The study will be comprised of two overnight sleep laboratory site visits. The clinic visits will be followed by a continuous ~48 hour in-home environment assessment period (defined as the subject's daily routine environment). During the sleep lab site visit, the subject and accompanying parent(s)/guardian(s) will sleep overnight at the facility. The subject will be video-recorded during the in-sleep lab visit, wear the wrist accelerometry devices, use the sleep sensor and complete assessments (Depending on age, parent/guardian may complete some assessments). Upon the completion of sleep lab activities the subjects will then continue to wear the wrist accelerometry devices, utilize the sleep sensor and complete Patient Reported Outcome/Clinical Outcome Assessments (PRO/COA) assessments during the 48 hour in-home assessment. At the conclusion of the in-home portion of the assessment, the subject will return the device/s and assessments to the facility and undergo brief assessments/interview.
- Conditions
- Atopic Dermatitis
- Being tested
- Wrist Actigraphy Devices, Sleep Monitor, 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
Sleep MonitorDevice
Also called EarlySense
Remote Sensor
PolysomnographyDevice
Sleep Monitor
VideographyDevice
Thermal Camera
| Study group | Role | What they receive |
|---|---|---|
| Monitoring scratch in children | Sensor technology and digital measures will be used to evaluate scratch and sleep in children with atopic dermatitis who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography. Receives: Device: Wrist Actigraphy Devices; Device: Sleep Monitor; 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
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.
Measured: From enrollment through the end of visit 5 (5 days +/- 2 days).
Quantification of sleep using Polysomnography
Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging based on the scoring guide provided by the American Academy of Sleep Medicine (AASM) for children. 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 (5 days +/- 2 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start14 Dec 2018
- Primary completion9 Jun 2020
- Study completion9 Jun 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.
- More trials run by Boston UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 62 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
- NCT03873220
- Sponsor's protocol ID
- H-37801
- Acronym
- MOSAIC
- Status last verified
- Nov 2020
- First submitted
- 11 Mar 2019
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility for Quantification of Scratch Behavior and Sleep in Children With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03873220
- Acronym / sponsor ID
- MOSAIC / H-37801
- Conditions
- Atopic Dermatitis
- Keywords
- Wearable devices, Scratch, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 13 Mar 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.
Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. The overall aim of this research is to validate the use of sensor technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients, and specifically in this study in children ages 2 to 11 years. To evaluate this experimental paradigm, the investigators propose using wearable accelerometers, a sleep sensor, PSG, videography and associated traditional patient-reported outcome measures/clinical outcome assessments (PRO/COA) in patients/caregivers with AD in a well-controlled in-laboratory and at-home study.
Detailed description
To assess the feasibility of quantifying scratch and sleep in children with Atopic Dermatitis (AD), children, age 2 to 11 years, with AD will be recruited. The subjects will complete specific questionnaires related to itch, sleeping habits and AD and continuously wear two wrist worn accelerometry devices. The EarlySense Sleep Monitor will also be placed underneath the mattress to measure additional sleep related activities.
The study will be comprised of two overnight sleep laboratory site visits. The clinic visits will be followed by a continuous ~48 hour in-home environment assessment period (defined as the subject's daily routine environment). During the sleep lab site visit, the subject and accompanying parent(s)/guardian(s) will sleep overnight at the facility. The subject will be video-recorded during the in-sleep lab visit, wear the wrist accelerometry devices, use the sleep sensor and complete assessments (Depending on age, parent/guardian may complete some assessments). Upon the completion of sleep lab activities the subjects will then continue to wear the wrist accelerometry devices, utilize the sleep sensor and complete Patient Reported Outcome/Clinical Outcome Assessments (PRO/COA) assessments during the 48 hour in-home assessment. At the conclusion of the in-home portion of the assessment, the subject will return the device/s and assessments to the facility and undergo brief assessments/interview.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring scratch in children | – | Device: Wrist Actigraphy Devices, Device: Sleep Monitor, Device: Polysomnography, Device: VideographySensor technology and digital measures will be used to evaluate scratch and sleep in children with atopic dermatitis who will wear watch-like wrist actigraphy devices, sleep monitor, polysomnography, and videography. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Individuals diagnosed with atopic dermatitis
Key inclusion criteria (4 listed)
- Male or female subjects aged ≥2 years of age and <12 years of age at Day 1.
- Written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable).
- Native English speakers or demonstrated fluency in English (both subject and parent(s)/guardian(s)).
- Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
Key exclusion criteria (3 listed)
- AD affected surface areas are in a location of device placement.
- Has unstable AD (Total BSA>40%).
- Has any planned surgical or medical procedure that would overlap with study participation.
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 | Monitoring scratch in children |
| Sleep MonitorAlso: EarlySenseRemote Sensor | Device | Monitoring scratch in children |
| PolysomnographySleep Monitor | Device | Monitoring scratch in children |
| VideographyThermal Camera | Device | Monitoring scratch in children |
Primary outcome
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry
Time frame: From enrollment through the end of visit 5 (5 days +/- 2 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.
Quantification of sleep using Polysomnography
Time frame: From enrollment through the end of visit 5 (5 days +/- 2 days).
Polysomnography (PSG) will be used to report the number of sleep occurrences and appropriate sleep staging based on the scoring guide provided by the American Academy of Sleep Medicine (AASM) for children. 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 1 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 4 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: finished, as of the sponsor's last update on 1 Dec 2020. 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 (time frame: From enrollment through the end of visit 5 (5 days +/- 2 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 1 Dec 2020.