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
- Conditions
- Obstructive Sleep ApneaAcute Coronary Syndrome
- Interventions
- Device: CPAP treatment
- Registration Number
- NCT02533050
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients treated CPAP treatment 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.
- Primary Outcome Measures
Name Time Method PASAT-4sec test score 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.
- Secondary Outcome Measures
Name Time Method Percentage (%) obtained in a test measurement of the reaction time Day 120 It is an other score obtained in psychometric tests. It is a psychometer vigilance test.
Percentage (%) for a N-back working memory task Day 120 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.
AHI Day 120 It is the number of apnea and hypopnea per hour. It determined by polysomnography.
The time (min) spent with a SaO2 below 90% Day 120 The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography.
Score Mini Mental State (MMS) Day 120 It is a score obtained in psychometric tests. This is a series of 30 questions that assesses cognitive and mnemonic ability of a person.
Mean time (ms) obtained in a Continus Performance Test Day 120 It is an other score obtained in psychometric tests. It measures a person's sustained and selective attention (associated with impulsivity and distractibility).
Average time (ms) for a N-back working memory task Day 120 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.
Mean nocturnal oxygen saturation (%) Day 120 It is a percentage index of hypoxemia measured by a polysomnography.
Minimal nocturnal oxygen saturation (%) Day 120 It is an other percentage index of hypoxemia measured by a polysomnography.
Mean time (ms) obtained in a test measurement of the reaction time Day 120 It is an other score obtained in psychometric tests. It is a psychometer vigilance test.
The oxyhemoglobin desaturation index Day 120 It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour
Sleep fragmentation Day 120 It is determined by a polysomnography.
Trial Locations
- Locations (1)
CHU de SAINT-ETIENNE
🇫🇷Saint-etienne, France