NCT04262791

A Non-Drug Study Detecting And Quantifying Nocturnal Scratch Behaviors From Wrist Actigraphy Data In Adult Healthy Volunteers And Participants With Atopic Dermatitis (AD)

A Multicenter, Non-Drug Interventional Study for the Technical Development and Validation of the Nocturnal Scratch Algorithm for Use in Future Programs

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Sleep disturbance is very common in patients with atopic dermatitis (AD) and is a major factor leading to impaired quality of life. Nocturnal scratching is one of the factors causing sleep disturbance in AD patients. This study aims to develop and validate a digital algorithm for accurately and reliably detecting and quantifying nocturnal scratch behaviors related to AD using wrist actigraphy data. Wrist actigraphy is an investigational device being developed to detect and quantify scratching behaviors in patients with AD. This study will be conducted in 2 sequential stages: In Stage 1, an algorithm will be developed and in Stage 2 the algorithm developed will be validated. Adult healthy volunteers or participants with AD will be enrolled. Approximately 14 healthy volunteers, 14 AD patients with low disease activity and 28 AD patients with high disease activity will be enrolled in the study in 5 sites across the United States. No drug will be administered as a part of this study. Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. Participants will be enrolled and monitored overnight for two consecutive nights at an inpatient setting at a hospital or clinic. The impact of nocturnal scratching on sleep parameters will be assessed by videography, actigraphy, sleep headband and completing questionnaires.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	Wrist Actigraphy Device	Wrist Actigraphy Device
DEVICE	Sleep Headband	Sleep Headband

Timeline

• Start date: 2020-02-17
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2020-02-10
• Last updated: 2022-02-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study