Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554496
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
XOR Levels in OSA Patients XOR-OSA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Obstructive Sleep Apnea Severity and Xanthine Oxidoreductase Activity Mechanisms and Clinical Implications
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XOR-OSA
Brief Summary:
The level of xanthine oxidoreductase XOR in plasma is associated with oxidative stress and inflammation Obstructive Sleep Apnea OSA is characterized by repeated upper airway obstruction and apneas during sleep leading to chronic intermittent hypoxemia The specific role of XOR in OSA its relationship with the severity of OSA and the changes in XOR levels before and after CPAP treatment remain unclear The study will enroll 80 patients from the First Affiliated Hospital of Nanjing Medical University categorized by their Apnea-Hypopnea Index AHI into mild moderate and severe OSA groups Participants will undergo baseline assessments including polysomnography PSG and measurements of XOR activity and biomarkers such as uric acid endothelin-1 ET-1 endothelial nitric oxide synthase eNOS and inflammatory markers Eligible patients will receive CPAP treatment for 3 months after which their XOR activity and biomarker levels will be re-evaluated to assess treatment efficacy
Detailed Description:
Xanthine oxidoreductase XOR is an enzyme involved in the oxidative metabolism of purines producing reactive oxygen species ROS as byproducts Elevated XOR activity is associated with increased oxidative stress and inflammation In patients with Obstructive Sleep ApneaOSA repeated episodes of hypoxia and reoxygenation lead to oxidative stress and inflammatory responses However the specific changes in XOR activity in OSA patients are not well understood
This study aims to evaluate the effects of Continuous Positive Airway Pressure CPAP treatment on patients with OSA by analyzing XOR activity and related biomarkers The primary objective is to assess the correlation between XOR activity levels and the severity of OSA and to determine how these levels change following a 3-month CPAP intervention
The study will enroll 80 patients aged 18-80 years from the First Affiliated Hospital of Nanjing Medical University Participants will be diagnosed with OSA according to established guidelines and must be first-time visitors with no prior OSA surgery or CPAP treatment history Patients with severe cerebrovascular diseases psychiatric conditions diagnosed diabetes with significant vascular complications severe COPD pulmonary hypertension heart failure or pregnancy will be excluded
All participants will undergo polysomnography PSG to determine the Apnea-Hypopnea Index AHI and categorize them into mild moderate or severe OSA groups
Blood samples will be collected to measure baseline XOR activity and related biomarkers including uric acid endothelin-1 ET-1 endothelial nitric oxide synthase eNOS C-reactive protein CRP tumor necrosis factor-alpha TNF-α interleukin-6 IL-6 malondialdehyde MDA superoxide dismutase SOD hypoxia-inducible factor-1 HIF-1 and angiotensin II Ang II
Eligible patients will receive CPAP therapy for a duration of 3 months Patients unsuitable for CPAP therapy will receive alternative treatments such as upper airway surgery oral appliances or weight reduction programs After 3 months of CPAP therapy participants will undergo follow-up PSG to reassess sleep parameters Blood samples will be collected again to measure changes in XOR activity and related biomarkers
The data collected will be analyzed using SPSS software Correlation analysis will be performed to assess the relationship between AHI lowest SpO2 oxygen load blood pressure load ESS sleepiness scores and XOR levels Paired t-tests will be used to compare pre- and post-treatment XOR activity and biomarker levels Repeated measures ANOVA will be conducted to evaluate the long-term changes and sustained effects of CPAP therapy
This study aims to provide a comprehensive understanding of the biochemical impacts of CPAP therapy on patients with OSAHS The findings are expected to identify potential biomarkers for assessing treatment efficacy and to guide future therapeutic strategies ultimately improving patient outcomes in clinical practice
This study aims to evaluate the effects of Continuous Positive Airway Pressure CPAP treatment on patients with OSA by analyzing XOR activity and related biomarkers The primary objective is to assess the correlation between XOR activity levels and the severity of OSA and to determine how these levels change following a 3-month CPAP intervention
The study will enroll 80 patients aged 18-80 years from the First Affiliated Hospital of Nanjing Medical University Participants will be diagnosed with OSA according to established guidelines and must be first-time visitors with no prior OSA surgery or CPAP treatment history Patients with severe cerebrovascular diseases psychiatric conditions diagnosed diabetes with significant vascular complications severe COPD pulmonary hypertension heart failure or pregnancy will be excluded
All participants will undergo polysomnography PSG to determine the Apnea-Hypopnea Index AHI and categorize them into mild moderate or severe OSA groups
Blood samples will be collected to measure baseline XOR activity and related biomarkers including uric acid endothelin-1 ET-1 endothelial nitric oxide synthase eNOS C-reactive protein CRP tumor necrosis factor-alpha TNF-α interleukin-6 IL-6 malondialdehyde MDA superoxide dismutase SOD hypoxia-inducible factor-1 HIF-1 and angiotensin II Ang II
Eligible patients will receive CPAP therapy for a duration of 3 months Patients unsuitable for CPAP therapy will receive alternative treatments such as upper airway surgery oral appliances or weight reduction programs After 3 months of CPAP therapy participants will undergo follow-up PSG to reassess sleep parameters Blood samples will be collected again to measure changes in XOR activity and related biomarkers
The data collected will be analyzed using SPSS software Correlation analysis will be performed to assess the relationship between AHI lowest SpO2 oxygen load blood pressure load ESS sleepiness scores and XOR levels Paired t-tests will be used to compare pre- and post-treatment XOR activity and biomarker levels Repeated measures ANOVA will be conducted to evaluate the long-term changes and sustained effects of CPAP therapy
This study aims to provide a comprehensive understanding of the biochemical impacts of CPAP therapy on patients with OSAHS The findings are expected to identify potential biomarkers for assessing treatment efficacy and to guide future therapeutic strategies ultimately improving patient outcomes in clinical practice
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