Clinical trial NCT02623088: CPAP Effect on Vascular Function in Obstructive Sleep Apnea
Official title: Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Endothelial dysfunction
Arterial stiffness
PAP therapies
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 107
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sleep apnea syndrome treated by CPAP after diagnosis and followed 5-7 years, as part of a clinical research.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long term evolution in arterial stiffness by pulse wave velocity
timeFrame: 4 to 7 years from baseline assessment
Secondary outcomes:
measure: Endothelial dysfunction by peripheral arterial tone
timeFrame: 4 to 7 years from baseline assessment
measure: Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling
timeFrame: 4 to 7 years from baseline assessment
measure: Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin
timeFrame: 4 to 7 years from baseline assessment
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis Pépin, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: