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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Grenoble, 프랑스, 38000
- University Hospital Grenoble
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Long term evolution in arterial stiffness by pulse wave velocity
기간: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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2차 결과 측정
결과 측정 |
기간 |
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Endothelial dysfunction by peripheral arterial tone
기간: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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Parameters of systemic inflammation : CRP us, TNF-α, IL-6 , Leptin in blood sampling
기간: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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Parameters of insulin resistance : glycated hemoglobin (HbA1C), blood sugar, insulin
기간: 4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-Louis Pépin, MDPhD, University Hospital, Grenoble
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 38RC14.422
- 2014-A01922-45 (기타 식별자: ID RCB)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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