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CPAP Effect on Vascular Function in Obstructive Sleep Apnea

Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02623088
Acronym
VNI-SOH2
Enrollment
107
Registered
2015-12-07
Start date
2015-04-30
Completion date
2016-03-31
Last updated
2016-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Endothelial dysfunction, Arterial stiffness, PAP therapies

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.

Interventions

OTHERPAP Therapies (CPAP)

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Long term evolution in arterial stiffness by pulse wave velocity4 to 7 years from baseline assessment

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026