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Ad Scientiam starts a clinical study leveraging smartphone and connected wearable

Sleep and Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy (ACTISLEEP)

Atopic dermatitis is a chronic disease with a high impact on patient's quality of life. Nocturnal pruritus is one of the main symptoms affecting quality of life. 

Treatment efficacy is generally measured by healthcare professionals during consultations with both questioning and visual examination of the lesions. Quality of Life (QoL) can also be evaluated retrospectively with the DLQI (Dermatology Life Quality Index) scale. 

Collecting data retrospectively introduces a significant recall bias that can be addressed by collecting data in real world (RW). RW data collection is prospective and takes place within the patient's own environment. 

While data collection is generally performed with diaries, it has been demonstrated that smartphones and connected devices are able to generate more precise and granular data than traditional methods. 

The main objective of the study is to demonstrate a medical hypothesis using a wristband actigraph and a smartphone application (Actisleep): patients with moderate to severe atopic dermatitis have a poorer quality and quantity of sleep than healthy subjects. 

Secondary objectives are to assess the interest of a smartphone application (Actisleep) in evaluating the quality of life of patients with moderate to severe atopic dermatitis versus that of healthy volunteers.

This study will involve 50 participants (30 patients and 20 healthy volunteers). It is coordinated by Prof. Martine Bagot (Head of the Department of Dermatology, Hôpital Saint-Louis, Paris)
The analysis of the participants' sleep data will be carried out by Prof. Damien Léger (Head of the Center for Sleep and Vigilance, Hôpital Hôtel-Dieu, Paris) and his team.

This study has received an institutional grant from REGENERON

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