Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Scratch and Sleep Quantification in Atopic Dermatitis (SQUAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490877
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Lisa Beck, University of Rochester

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.

Condition or disease
Atopic Dermatitis Pruritus Sleep Disturbance

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantification of Scratch and Sleep in Atopic Dermatitis
Actual Study Start Date : July 13, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching




Primary Outcome Measures :
  1. Scratch Movements [ Time Frame: 5 days ]
    To evaluate the agreement between the outcomes acquired by video annotation and accelerometry regarding scratch movement.

  2. 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.


Secondary Outcome Measures :
  1. Sleep Efficiency [ Time Frame: 5 days ]
    To evaluate the agreement between the outcomes of sleep efficiency acquired by polysomnography, sleep sensor pad and accelerometry.

  2. 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).

  3. 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).

  4. 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. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects, aged 12-75 years old, with active mild to severe atopic dermatitis (AD)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490877


Locations
Layout table for location information
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Pfizer
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Lisa Beck, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03490877    
Other Study ID Numbers: SQUAD1.0
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Beck, University of Rochester:
Atopic Dermatitis
Pruritus
Sleep Disturbance
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyssomnias
Sleep Wake Disorders
Parasomnias
Dermatitis, Atopic
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations