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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Montpellier、法国、34295
- CHU of MONTPELLIER
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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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假比较器：Sham Comparator
Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months
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三个月内假-持续气道正压通气并记录依从性
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage change of serum GSH/GSSG ratio
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
大体时间：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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|
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Change, after 3 months, of the catalase (parameters of serum oxidative stress level)
大体时间：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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|
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Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)
大体时间：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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|
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Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)
大体时间：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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Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)
大体时间：at the inclusion and the end (3 months) of the study
|
by blood test
|
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)
大体时间：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)
大体时间：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
大体时间：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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Change, after 3 months, of the MIBG scintigraphy
大体时间：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)
大体时间：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
大体时间：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
大体时间：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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Change, after 3 months, of the quality of sleep by PSQI questionnaire
大体时间：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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Change, after 3 months, of the sleepiness by the Epworth scale
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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