Attentional Capacity and Working Memory in Coronary Artery Disease Patients: Impact of the Presence of a Sleep Apnea Syndrome and Chronic Effects of Treatment With a Continuous Positive Airway Pressure System (CPAP). Etude CAPCORSAS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- PASAT-4sec test score
研究概览
简要总结
The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic patients do not complain in their daytime functioning. The objective of this study is to explore whether the objective cognitive assessment measures may be a good marker of the efficacy of CPAP treatment given to non-sleepy apneic CAD patients.
Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients should have a positive impact on cognitive performance, particularly on attention span and working memory measured by improvement in the Paced Auditory Serial Addition Test score (PASAT score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted to the Clinical Physiology Department of Exercise of the Saint Etienne University Hospital (myocardial infarction, coronary stenting or coronary artery bypass) and referred for care in cardiac rehabilitation
- •A native French speaker
- •No daytime sleepiness (ESS <or = 10)
- •Signature of informed consent by the patient
排除标准
- •Patients with a previous diagnosis of sleep apnea syndrome
- •Patients with severe heart failure (stage III and IV of the NYHA)
- •Patients with a neurodegenerative disease or other known cognitive disorders
- •Presence of progressive disease other than coronary artery disease (cancer for example)
- •Patients participating in other research that can change their cognitive function or drowsiness
研究组 & 干预措施
Patients non-treated
Patients with CAD and SAS. This patients should have an apnea-hypopnea index (AHI) between 15 and 40, and an ESS <10. After randomization, they will be not treated.
Patients treated
Patients with CAD and SAS. This patients should have an apnea-hypopnea index (AHI) between 15 and 40, and an Epworth sleepiness score (ESS) <10. After randomization, they will be treated with CPAP treatment.
干预措施: CPAP treatment (Device)
Control group
Patients with CAD but without SAS (AHI<15).
结局指标
主要结局
PASAT-4sec test score
时间窗: Day 120
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. Single digits are presented every 4 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT is the total number correct out of 60 possible answers.
次要结局
- Percentage (%) obtained in a test measurement of the reaction time(Day 120)
- Percentage (%) for a N-back working memory task(Day 120)
- AHI(Day 120)
- The time (min) spent with a SaO2 below 90%(Day 120)
- Score Mini Mental State (MMS)(Day 120)
- Mean time (ms) obtained in a Continus Performance Test(Day 120)
- Average time (ms) for a N-back working memory task(Day 120)
- Mean nocturnal oxygen saturation (%)(Day 120)
- Minimal nocturnal oxygen saturation (%)(Day 120)
- Mean time (ms) obtained in a test measurement of the reaction time(Day 120)
- The oxyhemoglobin desaturation index(Day 120)
- Sleep fragmentation(Day 120)