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
|Condition or disease|
|Atopic Dermatitis Pruritus Sleep Disturbance|
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|
|Actual Enrollment :||45 participants|
|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|
- Scratch Movements [ Time Frame: 5 days ]To evaluate the agreement between the outcomes acquired by video annotation and accelerometry regarding scratch movement.
- 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.
- Sleep Efficiency [ Time Frame: 5 days ]To evaluate the agreement between the outcomes of sleep efficiency acquired by polysomnography, sleep sensor pad and accelerometry.
- 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).
- 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).
- 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.
- 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.
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
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|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|