Obstructive Sleep ApneaCAPCORSASNCT02533050
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
A study testing CPAP treatment in people with Obstructive Sleep Apnea and Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Acute Coronary Syndrome
- What is being tested?
- CPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Obstructive Sleep Apnea, Acute Coronary Syndrome
- Being tested
- CPAP treatment
- Keywords
- obstructive sleep apnea, acute coronary event, cognitive functions, Continuous positive airway pressure night
- Medical subject headings
- Sleep Apnea, Obstructive, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated | Experimental | 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. Receives: Device: CPAP treatment |
| Patients non-treated | No intervention | 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. |
| Control group | No intervention | Patients with CAD but without SAS (AHI<15). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 120
Secondary outcomes (12)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 120
AHI
It is the number of apnea and hypopnea per hour. It determined by polysomnography.
Measured: Day 120
Mean nocturnal oxygen saturation (%)
It is a percentage index of hypoxemia measured by a polysomnography.
Measured: Day 120
Minimal nocturnal oxygen saturation (%)
It is an other percentage index of hypoxemia measured by a polysomnography.
Measured: Day 120
The oxyhemoglobin desaturation index
It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour
Measured: 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.
Measured: Day 120
Sleep fragmentation
It is determined by a polysomnography.
Measured: Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2014
- Primary completion24 Feb 2016
- Study completion29 Feb 2016
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic ROCHE, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533050
- Sponsor's protocol ID
- 1308171
- Other IDs
- 2013-A01635-40
- Acronym
- CAPCORSAS
- Status last verified
- Jan 2019
- First submitted
- 24 Aug 2015
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02533050
- Acronym / sponsor ID
- CAPCORSAS / 1308171
- Conditions
- Obstructive Sleep Apnea, Acute Coronary Syndrome
- Keywords
- obstructive sleep apnea, acute coronary event, cognitive functions, Continuous positive airway pressure night
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 24 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients treated | Experimental | Device: CPAP treatmentPatients 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 non-treated | No intervention | –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. |
| Control group | No intervention | –Patients with CAD but without SAS (AHI<15). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP treatmentPatients 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. | Device | Patients treated |
Primary outcome
PASAT-4sec test score
Time frame: 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.
12 secondary outcomes
Score Mini Mental State (MMS)
Time frame: Day 120
Mean time (ms) obtained in a Continus Performance Test
Time frame: Day 120
Percentage (%) obtained in a test measurement of the reaction time
Time frame: Day 120
Mean time (ms) obtained in a test measurement of the reaction time
Time frame: Day 120
Percentage (%) for a N-back working memory task
Time frame: Day 120
Average time (ms) for a N-back working memory task
Time frame: Day 120
AHI
Time frame: Day 120
Mean nocturnal oxygen saturation (%)
Time frame: Day 120
Minimal nocturnal oxygen saturation (%)
Time frame: Day 120
The oxyhemoglobin desaturation index
Time frame: Day 120
The time (min) spent with a SaO2 below 90%
Time frame: Day 120
Sleep fragmentation
Time frame: Day 120
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic ROCHE, MD PhD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP treatment in people with Obstructive Sleep Apnea and Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASAT-4sec test score (time frame: Day 120). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.