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 (CAPCORSAS)

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

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).

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea; Acute Coronary Syndrome
• Intervention / Treatment: Device: CPAP treatment

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CPAP treatment; 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.
No Intervention: 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.
No Intervention: Control group; Patients with CAD but without SAS (AHI<15).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): February 24, 2016
• Study Completion (Actual): February 29, 2016

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; cognitive functions; acute coronary event; Continuous positive airway pressure night
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Acute Coronary Syndrome
• Other Study ID Numbers: 1308171; 2013-A01635-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No