Clinical trial NCT03490877: Scratch and Sleep Quantification in Atopic Dermatitis
Official title: Quantification of Scratch and Sleep in Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Pruritus
Sleep Disturbance
Keywords: Atopic Dermatitis
Pruritus
Sleep Disturbance
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-04-06
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects, aged 12-75 years old, with active mild to severe atopic dermatitis (AD)

Brief summary: 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.

Detailed description: Wrist worn accelerometers, sleep sensors, 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. Our overall aim is to validate the use of accelerometry technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients in a home environment.

Accelerometry devices appear similar to a wristwatch. The subject will be asked to wear an accelerometry device on each wrist during the study. The accelerometry device provides continuous measures of wrist activity and will be used to quantify nocturnal scratching and sleep behaviors to be compared to videography (annotated for scratch), sleep sensor, PSG and traditional patient-reported outcome (PRO) and Quality of Life (QoL) measures \[Peak Pruritus Numerical Scale, Severity of Pruritus Scale (SPS), Patient Global Impression of Severity (PGIS), Medical Outcomes Study (MOS) Sleep Scale, Itch and Sleep Diary, Patient-Oriented Eczema Measure (POE), Patient-Reported Outcomes Measurement Information System (PROMIS)-pain interference, PROMIS- anxiety, Dermatology Life Quality Index (DLQI), Family Dermatology Life Quality Index (FDLQI), Children's Dermatology Life Quality Index (CDLQI), Device and Device Comfort Questionnaire\] in patients with AD in a clinic and home setting in a well-controlled clinical study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Scratch Movements
timeFrame: 5 days
measure: Sleep Time
timeFrame: 5 days
Secondary outcomes:
measure: Sleep Efficiency
timeFrame: 5 days
measure: Patient-Reported Outcomes/ Scratch
timeFrame: 5 days
measure: Patient-Reported Outcomes/ Sleep
timeFrame: 5 days
measure: Quality of Life/ Scratch
timeFrame: 5 days
measure: Quality of Life/ Sleep
timeFrame: 5 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Lisa A. Beck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester Medical Center/Center for Health+Technology
name: Earl R. Dorsey, MD MBA
role: STUDY_CHAIR
References: