Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure (CardioX SAS)
Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.
Investigators hypothesise that oxidative stress decrease after 3 months of continuous positive airway pressure (CPAP) in this specific population.
The results may have major implication in the comprehension of physiopathologic processes linking OSAS and CAD and in the treatment of OSAS in this specific population.
調査の概要
詳細な説明
Obstructive sleep apnea syndrome (OSAS) is a common disorder characterized by recurrent upper airway collapse during sleep and has been associated with worsened prognosis in patients with coronary artery disease (CAD). Moderate OSAS can be defined by an apnea hypopnea index (AHI) between 15 and 30 events/hour.
Pathophysiologic processes are complex and it seems that oxidative stress play and important role. Studies showed that continuous positive airway pressure (CPAP) influence oxidative stress but the results are conflicting.
Moreover there are uncertainties whether diagnosing and treating OSAS can influence the pathophysiological and clinical outcomes in patients with CAD.
Therefore, we aim to test the effects of 3 months of CPAP on systemic redox balance evaluated by plasma GSH/GSSG ratio.
Patients with moderate OSAS will be randomized for the intervention.
Patients with AHI <15/h or >30/h will be included in an ancillary study (blood and urinary test, MIBG scintigraphy) to characterize the biological profile of coronary patients based on their AHI.
For a alpha threshold of 5% and a study power of 80%, the study should include 16 patients in each group. Taking in account a possible 20% of dropout the study will need to include 20 patients by randomized arm to demonstrate an effect.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Montpellier、フランス、34295
- CHU of MONTPELLIER
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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
説明
Inclusion Criteria:
- Apnea Hypopnea Index 15-30/h
- Stable Coronary artery disease
- Obligation of obtaining informed consent form
Exclusion Criteria:
- Heart failure with LVEF less than or equal to 45%
- Other Chronic disease: renal failure, COPD Index - central apneas than or equal to 50% of the total IAH
- treatment with CPAP or mandibular advancement device
- IMC> 40 kg / m²
- Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins ...).
- Treatment with allopurinol or N-acetylcysteine, in the 4 weeks preceding the study.
- PaCO2> 45 mmHg - Counter-indication to the use of PPC: bullous lung disease, pathological hypotension, bypass airway, pneumothorax, signs of sinus infections or inner ear
- Exclusion period on subject compared to another protocol or for which the maximum annual amount of compensation of € 4,500 has been reached.
- Participation of the subject to another study.
- Not affiliated with a social security scheme subject or not the beneficiary of such a regime.
- Pregnant or breastfeeding women, patient unable to give consent, protected adult, vulnerable
- Subject deprived of liberty by judicial or administrative decision
- HIV infection, hepatitis B or hepatitis C known
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Experimental
Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months
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Continuous positive airway pressure treatment during three months with adherence recording
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偽コンパレータ：Sham Comparator
Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months
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3 か月間にわたる疑似継続的気道陽圧とアドヒアランス記録
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage change of serum GSH/GSSG ratio
時間枠：at the inclusion and the end (3 months) of the study
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Blood test
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at the inclusion and the end (3 months) of the study
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the catalase (parameters of serum oxidative stress level)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)
時間枠：at the inclusion and the end (3 months) of the study
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by blood test
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the GPX (parameter of serum oxidative stress level)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF α (blood test)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the urinary catecholamines by urine test
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the MIBG scintigraphy
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the endothelial function (endoPat)
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the blood pressure
時間枠：at the inclusion and the end (3 months) of the study
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24h ambulatory blood pressure monitoring
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the quality of life by the SF 36 questionnaire
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the quality of sleep by PSQI questionnaire
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the sleepiness by the Epworth scale
時間枠：at the inclusion and the end (3 months) of the study
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at the inclusion and the end (3 months) of the study
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Change, after 3 months, of the physical activity by the Voorips questionnaire
時間枠：at the inclusion and the end (3 months) of the study
|
at the inclusion and the end (3 months) of the study
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。
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