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

NCT05696496 | Active Not Recruiting

• 1 other identifier: RBHP 2022 FANTINI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorder

Keywords

video polysomnography; new sleep detection device

Outcome Measures

Primary Outcomes (2)

• Effective sleep duration (in minutes)

  evaluated by vPSG

  Month 6

• Effective sleep duration (in minutes)

  evaluated by ESM device

  Month 6

Secondary Outcomes (20)

• Time spent in bed (in minutes)

  Month 6

• Time spent in bed (in minutes)

  Month 6

• Sleep efficiency (Total sleep time/Time spent in bed)

  Month 6

• Sleep efficiency (Total sleep time/Time spent in bed)

  Month 6

• Sleep latency (in minutes)

  Month 6

Study Arms (2)

Patients with sleep disorders (TS+)

EXPERIMENTAL

video polysomnography; the new ESM "intelligent duvet" device

Device: night recording

control group without sleep disorder (TS-)

EXPERIMENTAL

video polysomnography; the new ESM "intelligent duvet" device

Device: night recording

Interventions

night recording DEVICE

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.

Patients with sleep disorders (TS+); control group without sleep disorder (TS-)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• refusing to participate in the study

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand, UMR INSERM 1107

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the 2 groups (patients with Sleep Disorder Group (TS+) and the control group (TS-)) will receive the same intervention.

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 25, 2023
• Study Start: January 25, 2023
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): July 25, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)