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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.
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:
First visit (baseline, inclusion visit, 30 minutes) which will include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with sleep disorders (TS+) | Experimental | video polysomnography; the new ESM "intelligent duvet" device |
|
| control group without sleep disorder (TS-) | Experimental | video polysomnography; the new ESM "intelligent duvet" device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
For Sleep Disorder Group (TS+):
For Control Group (TS- ):
Exclusion Criteria:
For Group TS+ and TS-:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand, UMR INSERM 1107 | Clermont-Ferrand | France |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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the 2 groups (patients with Sleep Disorder Group (TS+) and the control group (TS-)) will receive the same intervention.
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|
| 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 |
| D001523 | Mental Disorders |