CardioX SAS: Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT02893865

Collaborator

(none)

Enrollment

Location

Arms

62.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndrome Coronary Artery Disease	Device: Continuous positive airway pressure Device: Sham-continuous positive airway pressure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months	Device: Continuous positive airway pressure Continuous positive airway pressure treatment during three months with adherence recording
Sham Comparator: Sham Comparator Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months	Device: Sham-continuous positive airway pressure Sham-continuous positive airway pressure during three months with adherence recording

Arm

Intervention/Treatment

Experimental: Experimental

Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months

Device: Continuous positive airway pressure

Continuous positive airway pressure treatment during three months with adherence recording

Sham Comparator: Sham Comparator

Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months

Device: Sham-continuous positive airway pressure

Sham-continuous positive airway pressure during three months with adherence recording

Outcome Measures

Primary Outcome Measures

Percentage change of serum GSH/GSSG ratio [at the inclusion and the end (3 months) of the study]
Blood test

Secondary Outcome Measures

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]
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) [at the inclusion and the end (3 months) of the study]
by blood test
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 [at the inclusion and the end (3 months) of the study]
24h ambulatory blood pressure monitoring
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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