Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02893865
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2016-08-04
Brief Title:
Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CardioX SAS
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
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 eventshour
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 GSHGSSG ratio
Patients with moderate OSAS will be randomized for the intervention
Patients with AHI 15h or 30h 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
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 GSHGSSG ratio
Patients with moderate OSAS will be randomized for the intervention
Patients with AHI 15h or 30h 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None