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

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ClinicalTrials.gov Identifier: NCT02893865
Recruitment Status : Recruiting
First Posted : September 9, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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 Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. Percentage change of serum GSH/GSSG ratio [ Time Frame: at the inclusion and the end (3 months) of the study ]
    Blood test


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893865


Contacts
Contact: François Bughin, MD 0033467338284 f-bughin@chu-montpellier.fr

Locations
France
CHU of Montpellier Recruiting
Montpellier, France, 34295
Contact: François Bughin, MD    0033467338284    f-bughin@chu-montpellier.fr   
Principal Investigator: François Bughin, MD         
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02893865     History of Changes
Other Study ID Numbers: UF 9542
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by University Hospital, Montpellier:
Apnea syndrome
Coronary artery disease
Oxidative stress
Continuous positive airway pressure
Endothelial dysfunction

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Syndrome
Apnea
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases