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

NCT02533050 | Terminated

• 2 other identifiers: 13081712013-A01635-40
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea; Acute Coronary Syndrome

Keywords

obstructive sleep apnea; acute coronary event; cognitive functions; Continuous positive airway pressure night

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Score Mini Mental State (MMS)

  Day 120

• Mean time (ms) obtained in a Continus Performance Test

  Day 120

• Percentage (%) obtained in a test measurement of the reaction time

  Day 120

• Mean time (ms) obtained in a test measurement of the reaction time

  Day 120

• Percentage (%) for a N-back working memory task

  Day 120

Study Arms (3)

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.

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).

Interventions

CPAP treatment 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 treated

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Acute Coronary Syndrome

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Frederic ROCHE, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2014
• Primary Completion: February 24, 2016
• Study Completion: February 29, 2016
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)