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

September 24, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU of Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change of serum GSH/GSSG ratio
Time Frame: at the inclusion and the end (3 months) of the study
Blood test
at the inclusion and the end (3 months) of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the catalase (parameters of serum oxidative stress level)
Time Frame: at the inclusion and the end (3 months) of the study
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)
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)
Time Frame: at the inclusion and the end (3 months) of the study
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)
Time Frame: at the inclusion and the end (3 months) of the study
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)
Time Frame: at the inclusion and the end (3 months) of the study
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)
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the urinary catecholamines by urine test
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the MIBG scintigraphy
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the endothelial function (endoPat)
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the blood pressure
Time Frame: at the inclusion and the end (3 months) of the study
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
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the quality of sleep by PSQI questionnaire
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the sleepiness by the Epworth scale
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the physical activity by the Voorips questionnaire
Time Frame: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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