Scratch and Sleep Quantification in Atopic Dermatitis (SQUAD)

February 10, 2020 updated by: Lisa Beck, University of Rochester

Quantification of Scratch and Sleep in Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects, aged 12-75 years old, with active mild to severe atopic dermatitis (AD)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scratch Movements
Time Frame: 5 days
To evaluate the agreement between the outcomes acquired by video annotation and accelerometry regarding scratch movement.
5 days
Sleep Time
Time Frame: 5 days
To evaluate the agreement between the outcomes of amount of time asleep acquired by polysomnography, sleep sensor pad, and accelerometry.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Efficiency
Time Frame: 5 days
To evaluate the agreement between the outcomes of sleep efficiency acquired by polysomnography, sleep sensor pad and accelerometry.
5 days
Patient-Reported Outcomes/ Scratch
Time Frame: 5 days
To evaluate the agreement between the scratch outcomes acquired by accelerometry and patient-reported outcome (PRO) measures (as measured by the scales of the respective PROs).
5 days
Patient-Reported Outcomes/ Sleep
Time Frame: 5 days
To evaluate the agreement between the sleep outcomes acquired by accelerometry and patient-reported outcome (PRO) measures (as measured by the scales of the respective PROs).
5 days
Quality of Life/ Scratch
Time Frame: 5 days
To evaluate the agreement between the scratch outcomes acquired by accelerometry and quality of life measures, as measured by scores of the Quality of Life Questionnaires.
5 days
Quality of Life/ Sleep
Time Frame: 5 days
To evaluate the agreement between the sleep outcomes acquired by accelerometry and quality of life measures, as measured by scores of the Quality of Life Questionnaires.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Pfizer

Investigators

  • Principal Investigator: Lisa A. Beck, MD, University of Rochester
  • Study Chair: Earl R. Dorsey, MD MBA, University of Rochester Medical Center/Center for Health+Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQUAD1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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