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 CPAP

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Obstructive Sleep Apnea, Acute Coronary Syndrome

Intervention / Treatment
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* Device: CPAP treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated<br>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. | Device: CPAP treatment<br>* Patients treated wear a face mask during sleep which is connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airway and stimulate normal breathing.<br>|
| No Intervention: Patients non-treated<br>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. | |
| No Intervention: Control group<br>Patients with CAD but without SAS (AHI<15). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASAT-4sec test score | 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. | Day 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score Mini Mental State (MMS) | It is a score obtained in psychometric tests. This is a series of 30 questions that assesses cognitive and mnemonic ability of a person. | Day 120 | 
| Mean time (ms) obtained in a Continus Performance Test | It is an other score obtained in psychometric tests. It measures a person's sustained and selective attention (associated with impulsivity and distractibility). | Day 120 | 
| Percentage (%) obtained in a test measurement of the reaction time | It is an other score obtained in psychometric tests. It is a psychometer vigilance test. | Day 120 | 
| Mean time (ms) obtained in a test measurement of the reaction time | It is an other score obtained in psychometric tests. It is a psychometer vigilance test. | Day 120 | 
| Percentage (%) for a N-back working memory task | It is an other score obtained in psychometric tests. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. | Day 120 | 
| Average time (ms) for a N-back working memory task | It is an other score obtained in psychometric tests. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. | Day 120 | 
| AHI | It is the number of apnea and hypopnea per hour. It determined by polysomnography. | Day 120 | 
| Mean nocturnal oxygen saturation (%) | It is a percentage index of hypoxemia measured by a polysomnography. | Day 120 | 
| Minimal nocturnal oxygen saturation (%) | It is an other percentage index of hypoxemia measured by a polysomnography. | Day 120 | 
| The oxyhemoglobin desaturation index | It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour | Day 120 | 
| The time (min) spent with a SaO2 below 90% | The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography. | Day 120 | 
| Sleep fragmentation | It is determined by a polysomnography. | Day 120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, acute coronary event, cognitive functions, Continuous positive airway pressure night