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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03065-34 | Other Identifier | ID RCB |
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recruitment difficulty
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The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).
The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients PWV follow-up | Patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of cardiovascular events | Prevalence of cardiovascular events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire. | up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of metabolic events | Prevalence of metabolic events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire. | up to 15 years |
| Prevalence of incident cancers |
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Inclusion Criteria:
Exclusion Criteria:
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Sleep apnea patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness"
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis PEPIN, MD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Grenoble | 38706 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32234658 | Background | Bironneau V, Tamisier R, Trzepizur W, Andriantsitohaina R, Berger M, Goupil F, Joyeux-Faure M, Jullian-Desayes I, Launois S, Le Vaillant M, Martinez MC, Roche F, Pepin JL, Gagnadoux F. Sleep apnoea and endothelial dysfunction: An individual patient data meta-analysis. Sleep Med Rev. 2020 Aug;52:101309. doi: 10.1016/j.smrv.2020.101309. Epub 2020 Mar 13. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D003643 | Death |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Prevalence of incident cancers during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.. |
| up to 15 years |
| Prevalence of deaths | Prevalence of deaths during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire. | up to 15 years |
| Effect of CPAP treatment on the cardiovascular events occurrence | Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the cardiovascular events occurrence. | during 6 months |
| Effect of CPAP treatment on the metabolic events occurrence | Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the metabolic events occurrence. | during 6 months |
| Effect of CPAP treatment on the incident cancers occurrence | Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the incident cancers occurrence. | during 6 months |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |