Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring" — ESM  

Sleep Disorder Clinical Trial

Official title: Évaluation d'un Dispositif de détection du Sommeil " Easy Sleep Monitoring " (ou " Couette Intelligente ") Par Rapport à la vidéo-polysomnographie, Chez Des Patients Avec Des Troubles du Sommeil et Des Sujets Sains

Status Not yet recruiting

Clinical Trial Summary

If the video-polysomnographic (vPSG) recording in the laboratory remains the reference examination in Sleep Medicine Centers for the diagnosis of sleep pathologies, the high prevalence of sleep disorders in the general population and the growing demand for exploration and management may require the use of alternative techniques such as new sleep recording or analysis devices. In collaboration with the Creative Mechatronics Company (Issoire) and the Ennery Confection Company (Le Puy en Velay), we have developed a "portable" sleep detection prototype called Easy Sleep Monitoring (ESM) which consists of an "intelligent" duvet equipped with a series of sensors capable of detecting movements and, through this, estimating sleep duration and quantifying motor phenomena during sleep. Indeed, it is a duvet which has in its thickness a grid of 35 electronic cards, equipped with an actimetric sensor and a temperature sensor. The distribution of the sensors makes it possible to detect the motor activity of the sleeper on all the body regions by considerably increasing the sensitivity and specificity compared to actimetry at the wrist.

The advantage of this duvet compared to other "wearable" devices is represented by its ease of use, being less restrictive, having a reduced implementation time and not requiring the user's collaboration. For example, it could be used for sleep monitoring in the elderly and/or in a situation of hypomobility in the context of Residential establishment for dependent elderly people or hospitals. At home, it could be a sleep monitoring tool, such as monitoring treatment for insomnia, medicinal or not, or to monitor motor activity during sleep, as in the monitoring of nocturnal akinesia in parkinsonian patients.

The main objective of this study is to evaluate the concordance of sleep data obtained with the ESM duvet with those obtained by video-polysomnography (vPSG). Indeed, the vPSG is the gold standard examination in the study of sleep, the only one capable of exactly defining the different stages of sleep and precisely quantifying sleep disorders.

Clinical Trial Description

Type of study : monocentric study, a proof of concept study of a new device for sleep detection "Easy Sleep Monitoring" (ESM). This is a category 4.4 clinical investigation with a non-CE marked medical device used in its indication, without the objective of CE marking or establishing compliance

Number of centers: 1

Patients:

This study will be perdormed in 50 subjects (25 patients with sleep disorders (TS+) + 25 subjects without proven sleep disorders (TS-))

Study performance:

Each subject will have 2 visits:

1. First visit (baseline, inclusion visit, 30 minutes) which will include:

• Information and collection of written consent

• Recording of demographic and clinical data (age, sex, duration of disease progression, current treatments, medical and surgical history)

• Pittsburgh PSQI Sleep Quality Index (for TS- group only)

• Verification of inclusion and non-inclusion criteria.

2. Visit 2 (Month 6) (duration 1 night): The patients/controls will arrive in the evening at the Sleep Laboratory (Functional Exploration Department of the Nervous System of the Clermont-Ferrand University Hospital) to carry out complete vPSG and test the new ESM "intelligent duvet" device. ;

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT05696496
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 0473751195
• Email: promo_interne_drci@chu-clermontferrand.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2023
• Completion date: December 31, 2025