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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-02-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Obstructive Sleep Apnea Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CPAP treatment

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group

Patients with CAD but without SAS (AHI\<15).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No