Atopic Dermatitis With Accelerometry and Polysomnography (ADAP)
ADAP
Device Quantification of Scratch and Sleep in Atopic Dermatitis With Accelerometry and Polysomnography (ADAP) Study
1 other identifier
observational
88
1 country
1
Brief Summary
The purpose of this research is to better understand how wrist-worn study devices that measure activity/motion ('accelerometry devices') can be used to assess scratching and sleep in participants aged 12-75 years, with and without Atopic Dermatitis (AD, eczema), in both a sleep laboratory (hotel) setting and in a daily life/home setting. In this study, we will be using three different wrist devices to collect information: an Apple Watch Series 7, an Actigraph CentrePoint Insights Watch (CPIW) and a GENEActiv Original Watch. We will also compare the movement and sleep measurements recorded on the devices to thermal video and sleep assessments done in the sleep laboratory (hotel) as well as compare them to Patient Reported Outcome (PRO) assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedStudy Start
First participant enrolled
October 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2023
CompletedAugust 15, 2023
August 1, 2023
7 months
October 14, 2022
August 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Quantification of scratch using GENEActiv watches to assess triaxial accelerometry
One GENEActiv watch will be used on each wrist at a sampling rate of 100 Hz to measure movement in the x, y, and z direction.
14 days +/- 2 days
Quantification of scratch using Centrepoint Insights Watches (CPIW) to assess triaxial accelerometry
One CPIW watch will be used on each wrist at a sampling rate of 128 Hz to measure movement in the x, y, and z direction.
14 days +/- 2 days
Quantification of scratch using Apple Watches to assess triaxial accelerometry
One Apple Watch will be used on each wrist at a sampling rate of 100 Hz to measure movement in the x, y, and z direction.
14 days +/- 2 days
Quantification of sleep occurrences using polysomnography
Polysomnography (PSG) will be used to report the number of sleep occurrences based on the scoring guide provided by the American Academy of Sleep Medicine (AASM).
1 night
Sleep stage scoring using polysomnography
Polysomnography (PSG) will be used to report the appropriate sleep staging 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).
1 night
Study Arms (4)
Healthy Control
Those who do not have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Clear (0) or Almost Clear (1) on the Investigator's Static Global Assessment (ISGA) at intake.
Mild Atopic Dermatitis (AD)
Those who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Mild (2) on the Investigator's Static Global Assessment (ISGA) at intake.
Moderate Atopic Dermatitis (AD)
Those who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Moderate (3) on the Investigator's Static Global Assessment (ISGA) at intake.
Severe Atopic Dermatitis (AD)
Those who have a diagnosis of Atopic Dermatitis (AD) or eczema and score a Severe (4) on the Investigator's Static Global Assessment (ISGA) at intake.
Interventions
a watch like wearable sensor
a watch like wearable sensor
a watch like wearable sensor
Sleep monitor
Thermal Camera
Eligibility Criteria
Healthy Participants over or including the age of 12 and under the age of 75 Participants with Atopic Dermatitis (AD) over or including the age of 12 and under the age of 75
You may qualify if:
- Atopic Dermatitis (AD) Participants:
- Participants aged ≥12 years of age and \<75 years of age at Day 1.
- Written informed consent from participant or parent(s)/guardian(s) and assent from the participant (where assent is applicable).
- Participant (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 (participant; and parent(s)/guardian(s) as needed)
- Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (concomitant AD treatments are permitted on study).
- Have AD involvement ≥ 5% Treatable % Body Surface Area (BSA) excluding the scalp.
- Have an Investigator's Static Global Assessment (ISGA) score of Mild (2), Moderate (3) or Severe (4) at the screening visit within 14 days of study enrollment.
- Have a minimum Peak Pruritus Numerical Rating Scale (PP-NRS) assessment score of 3 (out of 10).
- Wide Range Achievement Test-4 (WRAT-4) Word Reading Subtest equivalent to 8th grade reading level or greater (for ages ≥18 years only).
- Healthy (non-AD) Participants:
- Participants aged ≥12 years of age and \<75 years of age at Day 1.
- Written informed consent from participant or parent(s)/guardian(s) and assent from the participant (where assent is applicable).
- Participant (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 (participant; and parent(s)/guardian(s) as needed)
- +3 more criteria
You may not qualify if:
- Atopic Dermatitis (AD) Participants:
- 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 participant's participation in study activities.
- Allergy to polyurethane resin (strap/wristband component).
- Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
- AD affected surface areas are in a location of device placement.
- If participant has a history of angioedema or anaphylaxis and has had any anaphylactic reactions within the past 6 months.
- Has unstable AD (Total BSA\>40%).
- Has a significant active systemic or localized infection, including actively infected AD.
- Has recently (within 30 days of Day 1) participated in or is currently involved in another drug or device research study for AD.
- Has any planned surgical or medical procedure that would overlap with study participation.
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are employees directly involved in the conduct of the study.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor) within 6 months of baseline as disclosed by participant during evaluation (for those participants over the age of 21).
- Is a female who is breastfeeding or pregnant, as disclosed by the participant.
- Current shift worker or travel across more than two time zones in the past 2 weeks, and/or during the study period.
- Participants with cardiac pacemakers, electronic pumps or any other implanted medical devices.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hampton Inn & Suites
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark B Moss, PhD
SymmetryScience Group, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2022
First Posted
October 17, 2022
Study Start
October 27, 2022
Primary Completion
May 11, 2023
Study Completion
May 11, 2023
Last Updated
August 15, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share