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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Grenoble、フランス、38000
- University Hospital Grenoble
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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Long term evolution in arterial stiffness by pulse wave velocity
時間枠：4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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二次結果の測定
結果測定 |
時間枠 |
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Endothelial dysfunction by peripheral arterial tone
時間枠：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
時間枠：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
時間枠：4 to 7 years from baseline assessment
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4 to 7 years from baseline assessment
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協力者と研究者
捜査官
- 主任研究者：Jean-Louis Pépin, MDPhD、University Hospital, Grenoble
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
閉塞性睡眠時無呼吸の臨床試験
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University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症（くも膜下出血）ドイツ
PAP Therapies (CPAP)の臨床試験
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VA Office of Research and Development募集閉塞性睡眠時無呼吸 | 物質使用障害 | 心的外傷後ストレス障害 | レジデンシャル トリートメント プログラムアメリカ
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Oslo University HospitalResMed; Medtronic; Norwegian Health Association完了
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Seattle Children's HospitalNationwide Children's Hospitalわからない
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Hugo W. Moser Research Institute at Kennedy Krieger...完了
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); Michigan Technological University完了
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McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR); American Thoracic Society完了