| Eligibility |
Inclusion Criteria:
Atopic Dermatitis (AD) Participants:
1. Participants aged =12 years of age and <75 years of age at Day 1.
2. Written informed consent from participant or parent(s)/guardian(s) and assent from the
participant (where assent is applicable).
3. Participant (and parent(s)/guardian(s)) are willing and able to comply with study
instructions, study visits, and procedures.
4. Native English speakers or demonstrated fluency in English (participant; and
parent(s)/guardian(s) as needed)
5. Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka
(concomitant AD treatments are permitted on study).
6. Have AD involvement = 5% Treatable % Body Surface Area (BSA) excluding the scalp.
7. 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.
8. Have a minimum Peak Pruritus Numerical Rating Scale (PP-NRS) assessment score of 3
(out of 10).
9. 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:
1. Participants aged =12 years of age and <75 years of age at Day 1.
2. Written informed consent from participant or parent(s)/guardian(s) and assent from the
participant (where assent is applicable).
3. Participant (and parent(s)/guardian(s)) are willing and able to comply with study
instructions, study visits, and procedures.
4. Native English speakers or demonstrated fluency in English (participant; and
parent(s)/guardian(s) as needed)
5. Does not have suspected or confirmed clinical diagnosis of AD (according to the
criteria of Hanifin and Rajka).
6. Have an ISGA score of Clear (0) or Almost Clear (1) at the screening visit within 14
days of study enrollment.
7. WRAT-4 Word Reading Subtest equivalent to 8th grade reading level or greater (for ages
=18 years only).
Exclusion Criteria:
Atopic Dermatitis (AD) Participants:
1. 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.
2. Allergy to polyurethane resin (strap/wristband component).
3. Has documented non-AD related insomnia, sleep apnea or other sleep-related disorders
(e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
4. AD affected surface areas are in a location of device placement.
5. If participant has a history of angioedema or anaphylaxis and has had any anaphylactic
reactions within the past 6 months.
6. Has unstable AD (Total BSA>40%).
7. Has a significant active systemic or localized infection, including actively infected
AD.
8. Has recently (within 30 days of Day 1) participated in or is currently involved in
another drug or device research study for AD.
9. Has any planned surgical or medical procedure that would overlap with study
participation.
10. 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.
11. 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).
12. Is a female who is breastfeeding or pregnant, as disclosed by the participant.
13. Current shift worker or travel across more than two time zones in the past 2 weeks,
and/or during the study period.
14. Participants with cardiac pacemakers, electronic pumps or any other implanted medical
devices.
Healthy (non-AD) Participants:
1. 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.
2. Allergy to polyurethane resin (strap/wristband component).
3. Has documented clinically diagnosed insomnia, sleep apnea or other sleep-related
disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder).
4. If participant has a history of angioedema or anaphylaxis and has had any anaphylactic
reactions within the past 6 months.
5. Has recently (within 30 days of Day 1) participated in or is currently involved in
another drug or device research study.
6. Has any planned surgical or medical procedure that would overlap with study
participation.
7. 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.
8. 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).
9. Is a female who is breastfeeding or pregnant, as disclosed by the participant.
10. Current shift worker or travel across more than two time zones in the past 2 weeks,
and/or during the study period.
11. Participants with cardiac pacemakers, electronic pumps or any other implanted medical
devices.
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