Scratch and Sleep Quantification in Atopic Dermatitis

NCT03490877 | Completed

• 1 other identifier: SQUAD1.0
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Pruritus; Sleep Disturbance

Keywords

Atopic Dermatitis; Pruritus; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• Scratch Movements

  To evaluate the agreement between the outcomes acquired by video annotation and accelerometry regarding scratch movement.

  5 days

• Sleep Time

  To evaluate the agreement between the outcomes of amount of time asleep acquired by polysomnography, sleep sensor pad, and accelerometry.

  5 days

Secondary Outcomes (5)

• Sleep Efficiency

  5 days

• Patient-Reported Outcomes/ Scratch

  5 days

• Patient-Reported Outcomes/ Sleep

  5 days

• Quality of Life/ Scratch

  5 days

• Quality of Life/ Sleep

  5 days

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• University of Rochester: lead
• Pfizer: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus; Parasomnias

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Lisa A. Beck, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Earl R. Dorsey, MD MBA

  University of Rochester Medical Center/Center for Health+Technology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 6, 2018
• Study Start: July 13, 2018
• Primary Completion: April 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

US (1)