Ignite Creation Date:
2024-05-06 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03490877
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-03-20
Brief Title:
Scratch and Sleep Quantification in Atopic Dermatitis
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Quantification of Scratch and Sleep in Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SQUAD
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
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 Childrens 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
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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None