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CPAP Effect on Vascular Function in Obstructive Sleep Apnea

Completed
Conditions
Obstructive Sleep Apnea
Interventions
Other: PAP Therapies (CPAP)
Registration Number
NCT02623088
Lead Sponsor
University Hospital, Grenoble
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
107
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
PAP therapiesPAP Therapies (CPAP)Patients with sleep apnea syndrome treated by CPAP after respiratory and vascular assessment and followed 5-7 years, as part of a clinical research.
Primary Outcome Measures
NameTimeMethod
Long term evolution in arterial stiffness by pulse wave velocity4 to 7 years from baseline assessment
Secondary Outcome Measures
NameTimeMethod
Endothelial dysfunction by peripheral arterial tone4 to 7 years from baseline assessment
Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling4 to 7 years from baseline assessment
Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin4 to 7 years from baseline assessment

Trial Locations

Locations (1)

University Hospital Grenoble

🇫🇷

Grenoble, France

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