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NCT Number: NCT02893865

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

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.

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Key information

Conditions

Sleep Apnea Syndrome Apnea Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyssomnias Heart Diseases Myocardial Ischemia Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU of Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

Continuous positive airway pressure treatment during three months with adherence recording

Sham-continuous positive airway pressure

Device

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

Primary outcomes

  1. Percentage change of serum GSH/GSSG ratio

    Time frame: at the inclusion and the end (3 months) of the study

    Blood test

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

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

    Time frame: at the inclusion and the end (3 months) of the study

  9. Change, after 3 months, of the MIBG scintigraphy

    Time frame: at the inclusion and the end (3 months) of the study

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

    Time frame: at the inclusion and the end (3 months) of the study

  11. 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

  12. 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

  13. 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

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

    Time frame: at the inclusion and the end (3 months) of the study

  15. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: CardioX SAS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2016
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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