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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)

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ClinicalTrials.gov Identifier: NCT02533050
Recruitment Status : Recruiting
First Posted : August 26, 2015
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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).


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Acute Coronary Syndrome Device: CPAP treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : August 2014
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Score Mini Mental State (MMS) [ Time Frame: Day 120 ]
    It is a score obtained in psychometric tests. This is a series of 30 questions that assesses cognitive and mnemonic ability of a person.

  2. Mean time (ms) obtained in a Continus Performance Test [ Time Frame: Day 120 ]
    It is an other score obtained in psychometric tests. It measures a person's sustained and selective attention (associated with impulsivity and distractibility).

  3. Percentage (%) obtained in a test measurement of the reaction time [ Time Frame: Day 120 ]
    It is an other score obtained in psychometric tests. It is a psychometer vigilance test.

  4. Mean time (ms) obtained in a test measurement of the reaction time [ Time Frame: Day 120 ]
    It is an other score obtained in psychometric tests. It is a psychometer vigilance test.

  5. Percentage (%) for a N-back working memory task [ Time Frame: Day 120 ]
    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.

  6. Average time (ms) for a N-back working memory task [ Time Frame: Day 120 ]
    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.

  7. AHI [ Time Frame: Day 120 ]
    It is the number of apnea and hypopnea per hour. It determined by polysomnography.

  8. Mean nocturnal oxygen saturation (%) [ Time Frame: Day 120 ]
    It is a percentage index of hypoxemia measured by a polysomnography.

  9. Minimal nocturnal oxygen saturation (%) [ Time Frame: Day 120 ]
    It is an other percentage index of hypoxemia measured by a polysomnography.

  10. The oxyhemoglobin desaturation index [ Time Frame: Day 120 ]
    It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour

  11. The time (min) spent with a SaO2 below 90% [ Time Frame: Day 120 ]
    The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography.

  12. Sleep fragmentation [ Time Frame: Day 120 ]
    It is determined by a polysomnography.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533050


Contacts
Contact: Frederic ROCHE, MD PhD (0)477828695 ext +33 frederic.roche@chu-st-etienne.fr
Contact: Arnauld GARCIN, CRA (0)477120286 ext +33 arnauld.garcin@chu-st-etienne.fr

Locations
France
CHU de SAINT-ETIENNE Recruiting
Saint-etienne, France, 42000
Sub-Investigator: Emilia SFORZA, MD         
Sub-Investigator: Jean-Claude BARTHELEMY, MD PhD         
Principal Investigator: Frédéric ROCHE, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Frederic ROCHE, MD PhD CHU de SAINT-ETIENNE

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02533050     History of Changes
Other Study ID Numbers: 1308171
2013-A01635-40 ( Other Identifier: ANSM )
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
obstructive sleep apnea
acute coronary event
cognitive functions
Continuous positive airway pressure night

Additional relevant MeSH terms:
Syndrome
Apnea
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Acute Coronary Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases