Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448689
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Analytical Validation of Wrist-Based Assessment of Nocturnal Scratch in Atopic Dermatitis and Psoriasis
Sponsor:
ActiGraph LLC
Organization:
ActiGraph LLC
Study Overview
Official Title:
Prospective Hybrid Single-Center Single-Arm Study to Characterize Sleep and Scratching Behavior in Adolescents and Adults With Atopic Dermatitis and Adults With Psoriasis
Status:
RECRUITING
Status Verified Date:
2024-06
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:
DECODE-Scratch
Brief Summary:
Pruritis is a common symptom in patients with atopic dermatitis and psoriasis Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life However nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients daily lives This study deploys multiple technologies polysomnography video capture wrist sensors clinician-reported outcomes and patient-reported outcomes to develop and validate a wrist-based solution to quantify nocturnal scratch
Detailed Description:
None
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