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Completed

NCT Number: NCT02623088

CPAP Effect 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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAP Therapies (CPAP)

Other

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

Other names: CPAP

Primary outcomes

  1. Long term evolution in arterial stiffness by pulse wave velocity

    Time frame: 4 to 7 years from baseline assessment

Secondary outcomes

  1. Endothelial dysfunction by peripheral arterial tone

    Time frame: 4 to 7 years from baseline assessment

  2. Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling

    Time frame: 4 to 7 years from baseline assessment

  3. Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin

    Time frame: 4 to 7 years from baseline assessment

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: VNI-SOH2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2015
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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