NCT03490877

Scratch and Sleep Quantification in Atopic Dermatitis

Quantification of Scratch and Sleep in Atopic Dermatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis
• Pruritus
• Sleep Disturbance

Timeline

• Start date: 2018-07-13
• Primary completion: 2019-04-30
• Completion: 2019-09-30
• First posted: 2018-04-06
• Last updated: 2020-02-12

Locations

1 site across 1 country: United States