Back to results

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

Primary Purpose

Sleep Apnea Syndrome, Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Continuous positive airway pressure

Sham-continuous positive airway pressure

About this trial

This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring Apnea syndrome, Coronary artery disease, Oxidative stress, Continuous positive airway pressure, Endothelial dysfunction

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU of Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental

Sham Comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage change of serum GSH/GSSG ratio

Blood test

Secondary Outcome Measures

Change, after 3 months, of the SOD (parameter of serum oxidative stress level)

Change, after 3 months, of the catalase (parameters of serum oxidative stress level)

Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)

Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)

Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)

by blood test

Change, after 3 months, of the GPX (parameter of serum oxidative stress level)

Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF α (blood test)

Change, after 3 months, of the urinary catecholamines by urine test

Change, after 3 months, of the MIBG scintigraphy

Change, after 3 months, of the endothelial function (endoPat)

Change, after 3 months, of the blood pressure

24h ambulatory blood pressure monitoring

Change, after 3 months, of the quality of life by the SF 36 questionnaire

Change, after 3 months, of the quality of sleep by PSQI questionnaire

Change, after 3 months, of the sleepiness by the Epworth scale

Change, after 3 months, of the physical activity by the Voorips questionnaire

Full Information

NCT ID

NCT02893865

First Posted

August 4, 2016

Last Updated

October 26, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02893865

Brief Title

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

Acronym

CardioX SAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

July 2021 (Actual)

Study Completion Date

July 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea Syndrome, Coronary Artery Disease

Keywords

Apnea syndrome, Coronary artery disease, Oxidative stress, Continuous positive airway pressure, Endothelial dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Comparator

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Continuous positive airway pressure

Intervention Description

Continuous positive airway pressure treatment during three months with adherence recording

Intervention Type

Device

Intervention Name(s)

Sham-continuous positive airway pressure

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage change of serum GSH/GSSG ratio

Description

Blood test

Time Frame