Evaluation of e New Sleep Detection Device "Easy Sleep Monitoring" (ESM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disorder
• Intervention / Treatment: Device: night recording

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand, UMR INSERM 1107
    • Principal Investigator: Livia Fantini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with sleep disorders (TS+); video polysomnography; the new ESM "intelligent duvet" device	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.
Experimental: control group without sleep disorder (TS-); video polysomnography; the new ESM "intelligent duvet" device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective sleep duration (in minutes)	evaluated by vPSG	Month 6
Effective sleep duration (in minutes)	evaluated by ESM device	Month 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2023
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: video polysomnography; new sleep detection device
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: RBHP 2022 FANTINI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No