Atopic Dermatitis With Accelerometry and Polysomnography (ADAP)

Completed

Conditions studied: Atopic Dermatitis, Eczema, Healthy

In brief

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.

Key facts

Study ID

NCT05583019

Run by

SymmetryScience Group, Inc.

People needed

88

Starts

2022-10-27

Expected to finish

2023-05-11

Last updated by the study team

2023-08-15

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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)
• Does not have suspected or confirmed clinical diagnosis of AD (according to the criteria of Hanifin and Rajka).
• Have an ISGA score of Clear (0) or Almost Clear (1) at the screening visit within 14 days of study enrollment.
• WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater (for ages ≥18 years only).

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.
• Healthy (non-AD) Participants:
• Has any clinically significant medical disorder, condition, disease (including any active/potentially recurrent dermatological conditions (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 clinically diagnosed insomnia, sleep apnea or other sleep-related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
• If participant has a history of angioedema or anaphylaxis and has had any anaphylactic reactions within the past 6 months.
• Has recently (within 30 days of Day 1) participated in or is currently involved in another drug or device research study.
• 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.

Where it is running

• Hampton Inn & Suites — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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