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

Obstructive Sleep Apnea Clinical Trial

— CAPCORSAS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02533050
• Other study ID #: 1308171
• Secondary ID: 2013-A01635-40
• Status: Terminated
• Phase: N/A
• Start date: August 2014
• Est. completion date: February 29, 2016

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 29, 2016
• Est. primary completion date: February 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Apnea
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	AHI	It is the number of apnea and hypopnea per hour. It determined by polysomnography.	Day 120
Secondary	Mean nocturnal oxygen saturation (%)	It is a percentage index of hypoxemia measured by a polysomnography.	Day 120
Secondary	Minimal nocturnal oxygen saturation (%)	It is an other percentage index of hypoxemia measured by a polysomnography.	Day 120
Secondary	The oxyhemoglobin desaturation index	It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour	Day 120
Secondary	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
Secondary	Sleep fragmentation	It is determined by a polysomnography.	Day 120