Clinical trial NCT02893865: Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
Official title: Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Coronary Artery Disease
Keywords: Apnea syndrome
Coronary artery disease
Oxidative stress
Continuous positive airway pressure
Endothelial dysfunction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Apnea Hypopnea Index 15-30/h
* Stable Coronary artery disease
* Obligation of obtaining informed consent form

Exclusion Criteria:

* Heart failure with LVEF less than or equal to 45%
* Other Chronic disease: renal failure, COPD Index - central apneas than or equal to 50% of the total IAH
* treatment with CPAP or mandibular advancement device
* IMC\> 40 kg / m²
* Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins ...).
* Treatment with allopurinol or N-acetylcysteine, in the 4 weeks preceding the study.
* PaCO2\> 45 mmHg - Counter-indication to the use of PPC: bullous lung disease, pathological hypotension, bypass airway, pneumothorax, signs of sinus infections or inner ear
* Exclusion period on subject compared to another protocol or for which the maximum annual amount of compensation of € 4,500 has been reached.
* Participation of the subject to another study.
* Not affiliated with a social security scheme subject or not the beneficiary of such a regime.
* Pregnant or breastfeeding women, patient unable to give consent, protected adult, vulnerable
* Subject deprived of liberty by judicial or administrative decision
* HIV infection, hepatitis B or hepatitis C known

Primary outcomes:
measure: Percentage change of serum GSH/GSSG ratio
timeFrame: at the inclusion and the end (3 months) of the study
Secondary outcomes:
measure: Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the catalase (parameters of serum oxidative stress level)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the GPX (parameter of serum oxidative stress level)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF α (blood test)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the urinary catecholamines by urine test
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the MIBG scintigraphy
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the endothelial function (endoPat)
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the blood pressure
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the quality of life by the SF 36 questionnaire
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the quality of sleep by PSQI questionnaire
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the sleepiness by the Epworth scale
timeFrame: at the inclusion and the end (3 months) of the study
measure: Change, after 3 months, of the physical activity by the Voorips questionnaire
timeFrame: at the inclusion and the end (3 months) of the study
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU of Montpellier
Study officials:
References: