CPAP Effect on Vascular Function in Obstructive Sleep Apnea (VNI-SOH2)
Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea
Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor.
Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events.
This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Obstructive sleep apnea (OSA) syndrome is responsible of vascular damage. Intermittent hypoxia causes oxidative stress and low-grade inflammation. By the way of increased sympathetic outflow, it's resulting endothelial dysfunction, atherosclerosis and an increase of arterial stiffness.
Finally these mechanisms are responsible of cardiovascular comorbidities: hypertension, cardiac arrhythmias or Left ventricular dysfunction. This patients presented coronary diseases or Strokes.
OSA characterized by intermittent hypoxia, is associated with atherosclerosis and vascular inflammation. Polymorphonuclear leukocytes (PMNs) are implicated in vascular inflammation by producing oxidizing radicals and proteolytic enzymes during PMN-endothelium interactions.
Reactive oxygen species (ROS) production is increased in activated cells and after attachment, PMNs release additional ROS inducing endothelial cell injury.
Continuous positive airway pressure (CPAP) is the current "gold standard" treatment for OSA, Use of CPAP restored the respiratory flow, prevents nocturnal respiratory events and daytime symptoms.
Arterial stiffness and endothelial dysfunction are linked to obstructive sleep apnea severity with a dose-effect relationship. And meta-analyse showed significant improvements in all indices of arterial stiffness after CPAP treatment in patients with OSA.
Assessment of pulse wave velocity and peripheral arterial tone are study measurements of arterial stiffness. And are strong predictors of late cardiovascular events
The investigators will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (Peripheral arterial tone) for patients with OSA treated by Positive Airway Pressure Therapies.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Grenoble, Francia, 38000
- University Hospital Grenoble
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Any patient with a initial visit there is 4-7 years for the VNI-SOH protocol (Réf CPP Sud-Est V: 38/2006/2)
- Male or female patient, aged 20-75 years at the initial visit there is 4 to 7 years;
- Patients with a BMI> 30kg / m2 at diagnostic;
- Patient affiliated to a social security;
- Having given its written consent to participate in the study.
Exclusion Criteria:
- Person private of liberty by judicial or administrative decision, person under legal protection measure (pregnant or nursing, patient under guardianship) Article L1121-8
- Exclusion period for further studies
- Patient died or lost sight since the initial visit there 4-7 years
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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PAP therapies
Patients with sleep apnea syndrome treated by CPAP after respiratory and vascular assessment and followed 5-7 years, as part of a clinical research.
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Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Long term evolution in arterial stiffness by pulse wave velocity
Lasso di tempo: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Endothelial dysfunction by peripheral arterial tone
Lasso di tempo: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling
Lasso di tempo: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin
Lasso di tempo: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jean-Louis Pépin, MDPhD, University Hospital, Grenoble
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 38RC14.422
- 2014-A01922-45 (Altro identificatore: ID RCB)
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