Scratch and Sleep Quantification in Atopic Dermatitis

Completed

Conditions studied: Atopic Dermatitis, Pruritus, Sleep Disturbance

In brief

Atopic dermatitis (AD) is a chronic type of eczema affecting approximately 10% of adults and 12% of children in the US. The intense itching (pruritus) associated with AD can be significantly disruptive to sleep and quality of life for both the patients and their caregivers. AD is challenging to describe and measure. The purpose of this study is to see if we can reliably measure how much people with AD scratch and how scratching interferes with sleep and quality of life by using digital sensors, sleep studies and patient-reported information.

Key facts

Study ID: NCT03490877
Run by: University of Rochester
People needed: 45
Starts: 2018-07-13
Expected to finish: 2019-09-30
Last updated by the study team: 2020-02-12

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female subjects aged > 12 to 75 years of age at the screening visit.
Written informed consent from participant (and parent/guardian for those subjects under 18 years of age) and able to understand and cooperate with study instructions, visits and procedures.
Native English speakers or fluent in English (per investigator's judgment)
Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (concomitant atopic dermatitis treatments are permitted on study).
Has AD involvement ≥ 5% Body Surface Area (BSA), excluding the scalp.
Has an Investigator's Static Global Assessment (ISGA) score of Mild (2), Moderate (3), or Severe (4) at the Screening Visit
Have a minimum Peak Pruritus Numerical Rating Score (NRS) of 3 and/or Severity of Pruritus Scale (SPS) score of 1.
Willingness to abstain from alcohol and illicit drugs on the day of the second overnight in-clinic study visit.

You may not qualify if…

Has any clinically significant medical disorder, condition, disease or clinically significant physical examination finding at screening that in the Investigator's or designee's opinion may interfere with study objectives (e.g., expose subject to unacceptable risk by study participation, confound evaluation, result in adverse events, or interfere with subject's ability to complete the study).
Has documented sleep apnea and/or other sleep related disorders (e.g., narcolepsy, restless legs syndrome, circadian rhythm disorder) or has a Body Mass Index (BMI) >35.
Subject scores <15 on the Asthma Control Test (ACT; Appendix C), indicating poorly controlled asthma.
Current shift worker or travel across more than two time zones in the past 2 weeks. (NOTE: for this travel criterion, subjects may enroll in the study if they delay enrollment until two weeks has lapsed since their travel).
If the patient has significant eczema at the location where the bilateral wrist devices will need to be worn, making the devices intolerable for the patient, and in the opinion of the patient or investigator would likely lead to noncompliance.
Has a significant active systemic or localized infection, including actively infected AD.
If subject has a history of angioedema or anaphylaxis, has not had any anaphylactic reactions within the past 6 months.
Has recently (within 30 days of the Screening Visit) 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.
Is a female who is breastfeeding or pregnant.
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 screening as disclosed by subject during evaluation

Where it is running

University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.