Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Percentage change of serum GSH/GSSG ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apnea Hypopnea Index 15-30/h
- •Stable Coronary artery disease
- •Obligation of obtaining informed consent form
排除标准
- •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
研究组 & 干预措施
Experimental
Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months
干预措施: Continuous positive airway pressure (Device)
Sham Comparator
Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months
干预措施: Sham-continuous positive airway pressure (Device)
结局指标
主要结局
Percentage change of serum GSH/GSSG ratio
时间窗: at the inclusion and the end (3 months) of the study
Blood test
次要结局
- Change, after 3 months, of the urinary catecholamines by urine test(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the MIBG scintigraphy(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the endothelial function (endoPat)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the blood pressure(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the quality of life by the SF 36 questionnaire(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the quality of sleep by PSQI questionnaire(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the sleepiness by the Epworth scale(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the physical activity by the Voorips questionnaire(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the SOD (parameter of serum oxidative stress level)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the catalase (parameters of serum oxidative stress level)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the GPX (parameter of serum oxidative stress level)(at the inclusion and the end (3 months) of the study)
- Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF α (blood test)(at the inclusion and the end (3 months) of the study)