CPAP Effect on Vascular Function in Obstructive Sleep Apnea

NCT ID: NCT02623088

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PAP Therapies (CPAP)

Intervention Type OTHER

Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.

Interventions

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PAP Therapies (CPAP)

Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.

Intervention Type OTHER

Other Intervention Names

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CPAP

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis Pépin, MDPhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01922-45

Identifier Type: OTHER

Identifier Source: secondary_id

38RC14.422

Identifier Type: -

Identifier Source: org_study_id

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