Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01069-34 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to compare the different variations of the cardiac variability index measured thanks to the technique developed by the CIC-IT between subjects with severe SAS and healthy subjects with sleep pathology.
In a first step, these two groups will be compared in REM sleep phase because it is the period during which the risk of sleep apnea syndrome is the highest. In a second step, the same methodology will be applied for the other sleep phases and correlations will be established with the other markers of cardiac variability (HRV) already known. This will allow to validate a reliable method of screening for SAS that is more accessible in ambulatory settings by means of a machine learning system based on artificial intelligence
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Arm "experimental" consists in questioners and polysomnography on patients with severe sleep apnea | ||
| Control group | Arm "control" consists in questioners and polysomnography on healthy subjects |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Ability of the high frequency variability index (HFVI) measured in REM sleep phase to differentiate subjects with severe SAS and healthy subjects with sleep pathology | Baseline (The day of the polysomnography ) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean value of the IVHF in the other sleep stages (N1, N2 and N3) | Variations of the IVHF between subjects with severe SAS and healthy subjects for the other sleep stages | Baseline (The day of the polysomnography ) |
| Mean value of other VFC variables in the different sleep stages (REM, N1, N2 and N3) |
Not provided
Inclusion Criteria:
Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.
Group 2 (subjects with severe SAS - 2): AHI > 30/h obstructive
Exclusion Criteria:
Non-inclusion criteria:
Cardiac rhythm disorder
Neurological or psychiatric pathology impacting on ANS
Control group (healthy subjects - 1)
Experimental group (subjects with severe SAS - 2):
o Associated sleep pathology at diagnosis of severe SAS
Administrative reasons:
Control group (healthy subjects - 1):
Not provided
Not provided
Recruitment of patients after the diagnosis of severe SAS in the services of the University Hospital of Lille. The healthy subjects will be recruited through an advertisement in the general medicine networks of the Hauts de France region.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe DERAMBURE, PR | Contact | 0320445962 | Philippe.DERAMBURE@chu-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe DERAMBURE, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille | Recruiting | Lille | France |
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Variations of the other markers of cardiac variability between subjects with severe SAS and healthy subjects for all sleep phases |
| Baseline (The day of the polysomnography ) |
| Total score and sub-score of the SCOPA-AUT questionnaire (between 0-69), with the possibility of analysis of the different sub-scores. | Variation of other nervous system components by standardized questionnaire between a group with severe SAS and a group of control subjects | Baseline (The day of the polysomnography ) |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |