Sleep Apnea SyndromeCardioX SASNCT02893865
Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
A study testing Continuous positive airway pressure in people with Sleep Apnea Syndrome and Coronary Artery Disease, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Sleep Apnea Syndrome, Coronary Artery Disease
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 29 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Apnea Hypopnea Index 15-30/h
- Stable Coronary artery disease
- Obligation of obtaining informed consent form
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea Syndrome, Coronary Artery Disease
- Being tested
- Continuous positive airway pressure, Sham-continuous positive airway pressure
- Keywords
- Apnea syndrome, Coronary artery disease, Oxidative stress, Continuous positive airway pressure, Endothelial dysfunction
- Medical subject headings
- Sleep Apnea Syndromes, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Continuous positive airway pressure treatment during three months with adherence recording
Sham-continuous positive airway pressureDevice
Sham-continuous positive airway pressure during three months with adherence recording
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months Receives: Device: Continuous positive airway pressure |
| Sham Comparator | Sham comparator | Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months Receives: Device: Sham-continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of serum GSH/GSSG ratio
Blood test
Measured: at the inclusion and the end (3 months) of the study
Secondary outcomes (15)
Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the catalase (parameters of serum oxidative stress level)
Measured: 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)
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)
Measured: 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
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the GPX (parameter of serum oxidative stress level)
Measured: 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)
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the urinary catecholamines by urine test
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the MIBG scintigraphy
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the endothelial function (endoPat)
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the blood pressure
24h ambulatory blood pressure monitoring
Measured: 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
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the quality of sleep by PSQI questionnaire
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the sleepiness by the Epworth scale
Measured: at the inclusion and the end (3 months) of the study
Change, after 3 months, of the physical activity by the Voorips questionnaire
Measured: at the inclusion and the end (3 months) of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893865
- Sponsor's protocol ID
- 9542
- Acronym
- CardioX SAS
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2016
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT02893865
- Acronym / sponsor ID
- CardioX SAS / 9542
- Conditions
- Sleep Apnea Syndrome, Coronary Artery Disease
- Keywords
- Apnea syndrome, Coronary artery disease, Oxidative stress, Continuous positive airway pressure, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Continuous positive airway pressureContinuous positive airway pressure Patients will receive continuous positive airway pressure during three months |
| Sham Comparator | Sham comparator | Device: Sham-continuous positive airway pressureSham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Apnea Hypopnea Index 15-30/h
- Stable Coronary artery disease
- Obligation of obtaining informed consent form
Key exclusion criteria (13 listed)
- 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 ...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressureContinuous positive airway pressure treatment during three months with adherence recording | Device | Experimental |
| Sham-continuous positive airway pressureSham-continuous positive airway pressure during three months with adherence recording | Device | Sham Comparator |
Primary outcome
Percentage change of serum GSH/GSSG ratio
Time frame: at the inclusion and the end (3 months) of the study
Blood test
15 secondary outcomes
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
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
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
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
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
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
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
Change, after 3 months, of the urinary catecholamines by urine test
Time frame: 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
Change, after 3 months, of the endothelial function (endoPat)
Time frame: 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
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
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
Change, after 3 months, of the sleepiness by the Epworth scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure in people with Sleep Apnea Syndrome and Coronary Artery Disease, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of serum GSH/GSSG ratio (time frame: at the inclusion and the end (3 months) of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.