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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: PAP Therapies (CPAP)

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.

• Study Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • University Hospital Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: PAP Therapies (CPAP); Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.; Other Names: CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long term evolution in arterial stiffness by pulse wave velocity	4 to 7 years from baseline assessment

Secondary Outcome Measures

Outcome Measure	Time Frame
Endothelial dysfunction by peripheral arterial tone	4 to 7 years from baseline assessment
Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling	4 to 7 years from baseline assessment
Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin	4 to 7 years from baseline assessment

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis Pépin, MDPhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 27, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Estimate): August 31, 2016
• Last Update Submitted That Met QC Criteria: August 30, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Endothelial dysfunction; Obstructive Sleep Apnea; Arterial stiffness; PAP therapies
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 38RC14.422; 2014-A01922-45 (Other Identifier: ID RCB)