Back to resultsAttentional 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)
Primary Purpose
Obstructive Sleep Apnea, Acute Coronary Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP treatment
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, acute coronary event, cognitive functions, Continuous positive airway pressure night
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
Sites / Locations
- CHU de SAINT-ETIENNE
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Patients treated
Patients non-treated
Control group
Arm Description
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.
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.
Patients with CAD but without SAS (AHI<15).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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.
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.
AHI
It is the number of apnea and hypopnea per hour. It determined by polysomnography.
Mean nocturnal oxygen saturation (%)
It is a percentage index of hypoxemia measured by a polysomnography.
Minimal nocturnal oxygen saturation (%)
It is an other percentage index of hypoxemia measured by a polysomnography.
The oxyhemoglobin desaturation index
It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour
The time (min) spent with a SaO2 below 90%
The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography.
Sleep fragmentation
It is determined by a polysomnography.
Full Information
NCT ID
NCT02533050
First Posted
August 24, 2015
Last Updated
January 28, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02533050
Brief 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 CPAP
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of inclusion
Study Start Date
August 2014 (Actual)
Primary Completion Date
February 24, 2016 (Actual)
Study Completion Date
February 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Acute Coronary Syndrome
Keywords
obstructive sleep apnea, acute coronary event, cognitive functions, Continuous positive airway pressure night
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients treated
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients non-treated
Arm Type
No Intervention
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients with CAD but without SAS (AHI<15).
Intervention Type
Device
Intervention Name(s)
CPAP treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
PASAT-4sec test score
Description
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.
Time Frame
Day 120
Secondary Outcome Measure Information:
Title
Score Mini Mental State (MMS)
Description
It is a score obtained in psychometric tests. This is a series of 30 questions that assesses cognitive and mnemonic ability of a person.
Time Frame
Day 120
Title
Mean time (ms) obtained in a Continus Performance Test
Description
It is an other score obtained in psychometric tests. It measures a person's sustained and selective attention (associated with impulsivity and distractibility).
Time Frame
Day 120
Title
Percentage (%) obtained in a test measurement of the reaction time
Description
It is an other score obtained in psychometric tests. It is a psychometer vigilance test.
Time Frame
Day 120
Title
Mean time (ms) obtained in a test measurement of the reaction time
Description
It is an other score obtained in psychometric tests. It is a psychometer vigilance test.
Time Frame
Day 120
Title
Percentage (%) for a N-back working memory task
Description
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.
Time Frame
Day 120
Title
Average time (ms) for a N-back working memory task
Description
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.
Time Frame
Day 120
Title
AHI
Description
It is the number of apnea and hypopnea per hour. It determined by polysomnography.
Time Frame
Day 120
Title
Mean nocturnal oxygen saturation (%)
Description
It is a percentage index of hypoxemia measured by a polysomnography.
Time Frame
Day 120
Title
Minimal nocturnal oxygen saturation (%)
Description
It is an other percentage index of hypoxemia measured by a polysomnography.
Time Frame
Day 120
Title
The oxyhemoglobin desaturation index
Description
It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour
Time Frame
Day 120
Title
The time (min) spent with a SaO2 below 90%
Description
The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography.
Time Frame
Day 120
Title
Sleep fragmentation
Description
It is determined by a polysomnography.
Time Frame
Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic ROCHE, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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