Clinical trial NCT02533050: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Acute Coronary Syndrome
Keywords: obstructive sleep apnea
acute coronary event
cognitive functions
Continuous positive airway pressure night
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: PASAT-4sec test score
timeFrame: Day 120
Secondary outcomes:
measure: Score Mini Mental State (MMS)
timeFrame: Day 120
measure: Mean time (ms) obtained in a Continus Performance Test
timeFrame: Day 120
measure: Percentage (%) obtained in a test measurement of the reaction time
timeFrame: Day 120
measure: Mean time (ms) obtained in a test measurement of the reaction time
timeFrame: Day 120
measure: Percentage (%) for a N-back working memory task
timeFrame: Day 120
measure: Average time (ms) for a N-back working memory task
timeFrame: Day 120
measure: AHI
timeFrame: Day 120
measure: Mean nocturnal oxygen saturation (%)
timeFrame: Day 120
measure: Minimal nocturnal oxygen saturation (%)
timeFrame: Day 120
measure: The oxyhemoglobin desaturation index
timeFrame: Day 120
measure: The time (min) spent with a SaO2 below 90%
timeFrame: Day 120
measure: Sleep fragmentation
timeFrame: Day 120
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Frederic ROCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: