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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2026-A00074-47 |
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| Name | Class |
|---|---|
| Saint Etienne School of Mine | OTHER |
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To diagnose sleep disorders, practitioners primarily use polysomnography (PSG), a precise but costly, cumbersome method that is limited to a single observation. This does not allow for longitudinal monitoring of sleep habits in real-world conditions. An alternative is offered with the C. Santé software receiving information from sensors installed on medical bed. This software analyzes cardiorespiratory parameters and sleep phases without disturbing the patient, enabling continuous and comfortable monitoring. A preliminary study aims to validate the reliability of the C. Santé software analysis, by comparing it to the PSG analysis, considered the gold standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polysomnography | Experimental | The patients will spend two consecutive nights on the bed equipped with C. Santé software which is also equipped with traditional polysomnography. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C. Santé software compared to polysomnography | Diagnostic Test | Patients visit the Sleep Unit at the Clinique Mutualiste for sleep disorders. During their consultation with the doctor, a polysomnography scheduled over two consecutive nights is proposed (this applies to any diagnosis of sleep disorders). At that time, they are also invited to participate in the study. After receiving information about the study and signing the consent form, the patient returns for their two consecutive nights equipped with PSG, which they spend on the bed equipped with sensors transmitting information to C. Santé software. |
| Measure | Description | Time Frame |
|---|---|---|
| The agreement in sleep efficiency measurement performed C. Santé software compared to polysomnography (PSG). | The study's objective will be met if the sleep efficiency measured by PSG and that calculated from C. Santé software differ by no more than 10%. This means the device will be considered effective if there is at least 90% agreement between PSG and the C. Santé software. | "Up to 3 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of RR interval measurement | Determined from the ECG trace of the PSG compared to the C. Santé software | Up to 3 months after inclusion |
| Accuracy of sleep phase duration measurement | Comparing PSG-calculated durations for sleep stages (N1: light slowwave sleep, N2: intermediate slow-wave sleep, N3: deep slow-wave sleep, REM: rapid eye movement sleep) to the C. Santé software calculation for slow-wave sleep (N) and REM. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno STIMMESSE, MD | Contact | (0)4 82 77 48 58 | +33 | bstimmesse@mutualite-loire.com |
| Clara PFENNINGER, CDP | Contact | (0)4 77 12 08 26 | +33 | clara.pfenninger@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric ROCHE, MD PhD | CHU de Saint-Etienne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Mutualiste | Saint-Etienne | 42000 | 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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| Up to 3 months after inclusion |
| Accuracy of respiratory rate measurement | Comparing C. Santé software measurements to nasal cannula measurements from PSG (analyzed in 30-second intervals) | Up to 3 months after inclusion |
| Accuracy in positional data | Comparing the time spent lying on the back or side and the number of position changes as calculated by PSG (via a thoracic accelerometer) and by C. Santé software. | Up to 3 months after inclusion |
| Differences in measurements across two consecutive nights | Differences in measurements across two consecutive nights | Up to 3 months after inclusion |
| D001523 | Mental Disorders |