NCT05467046

Clinical Relevance of Scratching and Sleep in Atopic Dermatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice. In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.

Detailed description

The study consists of two consecutive parts. In part 1, 30 AD-patient will be asked to wear a smartwatch during nighttime and to complete questionnaires regarding the usability of the smartwatch system. In part 2, a focus group with dermatology Health Care Practitioners (HCPs) will take place. In this focus group, the HCPs will evaluate whether the scratching and sleep parameters obtained from the smartwatches worn by the AD-patients in part 1, provide added value for clinical practice in dermatology. The primary objective is to collect insights in whether objectification of scratching and sleep in AD-patients during the night provides added value for clinical practice in dermatology. The secondary objective is to collect insights into the requirements of AD-patients and dermatology HCPs for a smartwatch system to be acceptable for use in the dermatology clinical practice.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	Smartwatch system	The Atopic Dermatitis patient cohort is exposed to using a smartwatch system for 5 weeks.

Timeline

• Start date: 2022-08-03
• Primary completion: 2023-09-30
• Completion: 2023-12-07
• First posted: 2022-07-20
• Last updated: 2024-04-03

Locations

1 site across 1 country: Netherlands