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

Coronary Artery Disease Clinical Trial

— CardioX SAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893865
• Other study ID #: UF 9542
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: July 29, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 29, 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Intervention

Device:
• Continuous positive airway pressure
Continuous positive airway pressure treatment during three months with adherence recording
• Sham-continuous positive airway pressure
Sham-continuous positive airway pressure during three months with adherence recording

Locations

Country	Name	City	State
France	CHU of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change of serum GSH/GSSG ratio	Blood test	at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the SOD (parameter of serum oxidative stress level)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the catalase (parameters of serum oxidative stress level)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)	by blood test	at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the GPX (parameter of serum oxidative stress level)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF a (blood test)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the urinary catecholamines by urine test		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the MIBG scintigraphy		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the endothelial function (endoPat)		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the blood pressure	24h ambulatory blood pressure monitoring	at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the quality of life by the SF 36 questionnaire		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the quality of sleep by PSQI questionnaire		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the sleepiness by the Epworth scale		at the inclusion and the end (3 months) of the study
Secondary	Change, after 3 months, of the physical activity by the Voorips questionnaire		at the inclusion and the end (3 months) of the study