Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.
Investigators hypothesise that oxidative stress decrease after 3 months of continuous positive airway pressure (CPAP) in this specific population.
The results may have major implication in the comprehension of physiopathologic processes linking OSAS and CAD and in the treatment of OSAS in this specific population.
Obstructive sleep apnea syndrome (OSAS) is a common disorder characterized by recurrent upper airway collapse during sleep and has been associated with worsened prognosis in patients with coronary artery disease (CAD). Moderate OSAS can be defined by an apnea hypopnea index (AHI) between 15 and 30 events/hour.
Pathophysiologic processes are complex and it seems that oxidative stress play and important role. Studies showed that continuous positive airway pressure (CPAP) influence oxidative stress but the results are conflicting.
Moreover there are uncertainties whether diagnosing and treating OSAS can influence the pathophysiological and clinical outcomes in patients with CAD.
Therefore, we aim to test the effects of 3 months of CPAP on systemic redox balance evaluated by plasma GSH/GSSG ratio.
Patients with moderate OSAS will be randomized for the intervention.
Patients with AHI <15/h or >30/h will be included in an ancillary study (blood and urinary test, MIBG scintigraphy) to characterize the biological profile of coronary patients based on their AHI.
For a alpha threshold of 5% and a study power of 80%, the study should include 16 patients in each group. Taking in account a possible 20% of dropout the study will need to include 20 patients by randomized arm to demonstrate an effect.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months |
|
| Sham Comparator | Sham Comparator | Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | Continuous positive airway pressure treatment during three months with adherence recording |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change of serum GSH/GSSG ratio | Blood test | at the inclusion and the end (3 months) of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Change, after 3 months, of the SOD (parameter of serum oxidative stress level) | at the inclusion and the end (3 months) of the study | |
| Change, after 3 months, of the catalase (parameters of serum oxidative stress level) | at the inclusion and the end (3 months) of the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU of Montpellier | Montpellier | 34295 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham-continuous positive airway pressure | Device | Sham-continuous positive airway pressure during three months with adherence recording |
|
| Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level) | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level) | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level) | by blood test | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the GPX (parameter of serum oxidative stress level) | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF α (blood test) | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the urinary catecholamines by urine test | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the MIBG scintigraphy | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the endothelial function (endoPat) | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the blood pressure | 24h ambulatory blood pressure monitoring | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the quality of life by the SF 36 questionnaire | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the quality of sleep by PSQI questionnaire | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the sleepiness by the Epworth scale | at the inclusion and the end (3 months) of the study |
| Change, after 3 months, of the physical activity by the Voorips questionnaire | at the inclusion and the end (3 months) of the study |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided