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

Sleep Disorder Clinical Trial

— ESM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696496
• Other study ID #: RBHP 2022 FANTINI
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 0473751195
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

For Sleep Disorder Group (TS+):

• Men or women, aged 18 to 85

• With a suspected sleep disorder (sleep apnea, restless legs syndrome RLS, syndrome of periodic leg movements during MPJS sleep, REM sleep behavior disorder, Parkinson's disease, Narcolepsy, etc.), requiring a confirmation of the diagnosis in vPSG.

• Cooperation and understanding to strictly comply with the conditions set out in the protocol - Acceptance of the protocol and signing of a written consent

• Affiliation to the social security system

For Control Group (TS- ):

• Men or women, aged 18 to 85

• Having no sleep disorder: the Pittsburgh PSQI sleep quality index (Buysse et al., 1989) must be <5.

• Cooperation and understanding to strictly comply with the conditions set out in the protocol - Acceptance of the protocol and signing of a written consent

• Affiliation to the social security system

Exclusion Criteria:

For Group TS+ and TS-:

• Patients under guardianship or curatorship or safeguard of justice

• Pregnant or breastfeeding women (given the low risk incurred, the verification will be done on simple declaration of the patient)

• Patients with active implants

• during a period of exclusion from another study,

• refusing to participate in the study

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• night recording
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. A qualified technician will place the electrodes according to the procedures usually followed at the Sleep Center for vPSG recording. The ESM duvet will be placed on the patient's body as a blanket, instead of the blankets normally provided by the hospital. Patients/controls will be monitored overnight by an infrared video camera.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand, UMR INSERM 1107	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective sleep duration (in minutes)	evaluated by vPSG	Month 6
Primary	Effective sleep duration (in minutes)	evaluated by ESM device	Month 6
Secondary	Time spent in bed (in minutes)	evaluated by vPSG	Month 6
Secondary	Time spent in bed (in minutes)	evaluated by ESM device	Month 6
Secondary	Sleep efficiency (Total sleep time/Time spent in bed)	evaluated by vPSG	Month 6
Secondary	Sleep efficiency (Total sleep time/Time spent in bed)	evaluated by ESM device	Month 6
Secondary	Sleep latency (in minutes)	evaluated by vPSG	Month 6
Secondary	Sleep latency (in minutes)	evaluated by ESM device	Month 6
Secondary	Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)(in minutes)	evaluated by vPSG	Month 6
Secondary	Duration of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep) (in minutes)	evaluated by ESM device	Month 6
Secondary	% of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)	evaluated by vPSG	Month 6
Secondary	% of sleep stages (Deep Wave Sleep vs. Paradoxical Sleep)	evaluated by ESM device	Month 6
Secondary	Number of alarm clocks	evaluated by vPSG	Month 6
Secondary	Number of alarm clocks	evaluated by ESM device	Month 6
Secondary	Number of position changes	evaluated by vPSG	Month 6
Secondary	Number of position changes	evaluated by ESM device	Month 6
Secondary	Duration of periodic movements of the lower limbs (in minutes)	evaluated by vPSG	Month 6
Secondary	Duration of periodic movements of the lower limbs (in minutes)	evaluated by ESM device	Month 6
Secondary	Duration of Cheyne-Stokes periodic breathing (in minutes)	evaluated by vPSG	Month 6
Secondary	Duration of Cheyne-Stokes periodic breathing (in minutes)	evaluated by ESM device	Month 6
Secondary	number of obstructive and central apneas	evaluated by vPSG	Month 6
Secondary	number of obstructive and central apneas	evaluated by ESM device	Month 6