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Obstructive sleep apnea (OSA) is highly prevalent in chronic kidney disease (CKD) patients and strongly linked to obesity, metabolic syndrome, and type 2 diabetes. Besides elevating cardiovascular disease risk, OSA may worsen renal function and diminish quality of life, making its understanding critical for CKD patient health.
This study will establish a large, long-term cohort of non-dialysis CKD patients to identify OSA risk factors, explore OSA's association with adverse renal outcomes, and determine OSA prevalence and epidemiological characteristics within the CKD population. The findings will provide a scientific foundation for early OSA identification, diagnosis, and intervention in CKD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronic kidney diseases with OSA |
| ||
| chronic kidney diseases without OSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Progression of Chronic Kidney Diseases in CKD Patients | the progression of chronic kidney diseases is defined as: Patients had a 40% or a greater decrease in baseline eGFR(estimated Glomerular Filtration Rate); End-Stage Renal Disease (eGFR< 15 ml/min/1.73 m2, initiation of renal replacement therapy or renal transplantation ) | six months |
| Renal death or Cardiovascular death | Deaths Directly Caused by Renal or Cardiovascular Dysfunction or Their Acute or Chronic Complications | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events(MACE) | Composite endpoint including: Non-fatal myocardial infarction, Non-fatal stroke, Hospitalization due to unstable angina, heart failure, or transient ischemic attack (TIA), Cardiovascular (CV) death. | six months |
| Cardiovascular Adverse Events |
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Inclusion Criteria:
Voluntarily sign the informed consent form;
Exclusion Criteria:
Patients receiving oxygen therapy or continuous positive airway pressure (CPAP) treatment;
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The participants will be recruited from department of Nephrology, Nanfang Hospital
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Individual components of the MACE composite endpoint. |
| six months |
| 24-hour urine protein(g/24h) | Total protein excreted in urine over 24 hours. Normal Range: <0.15 g/24h. Moderate proteinuria: >2.8 g/24h, suggestive of active glomerular disease. | six months |
| Rate of eGFR Decline(mL/min/1.73m²/year) | Annualized decline in eGFR(estimated glomerular filtration rate). Decline Rate = Baseline eGFR - Follow-up eGFR. Normal decline rate: <-3 mL/min/1.73m²/year. Rate of eGFR Decline >5 mL/min/1.73m²/year indicating rapid progression. | six months |
| Doubling of Serum Creatinine | A sustained ≥100% increase in serum creatinine(μmol/L) from baseline. Acute Kidney Injury: Occurring within 7 days. CKD progression: Over ≥3 months. | six months |
| Cardiovascular Death | Death due to cardiovascular events | six months |
| All-Cause Death | Death from any cause during the study period. | six months |
| Apnea-Hypopnea Index (AHI) | Apnea: Complete cessation of airflow for ≥10 seconds. Hypopnea: Reduction in airflow by ≥30% accompanied by either ≥3% oxygen desaturation or an arousal (brief awakening). AHI = (Number of apneas + Number of hypopneas) / Total sleep hours. AHI for classifying the severity of sleep apnea. Mild Sleep Apnea: AHI 5-15 events/hour. Moderate Sleep Apnea: AHI 15-30 events/hour. Severe Sleep Apnea: AHI >30 events/hou. | 1 year |
| Mean Blood Pressure(MBP, mmHg) | Average pressure in arteries during one cardiac cycle. Calculated from systolic and diastolic blood pressure. MBP=Diastolic BP+ 1/3*(Systolic BP-Diastolic BP). Approximately 70-100 mmHg (varies with age and health status). | 1 year |
| Corrected QT Interval (QTc, ms) | Heart rate-adjusted duration of ventricular depolarization and repolarization. normal range:Adult males ≤440 ms;Adult females ≤460 ms. Significant Prolongation >480 ms (Regardless of gender). | 1 year |
| left ventricular ejection fraction (LVEF, %) | Percentage of blood ejected from the left ventricle per heartbeat. Normal Range:55%-70% ; Mildly Reduced:41%-49%; Moderately Reduced:30%-40%; Severely Reduced:<30%. | 1 year |
| Carotid Ultrasound Measurement Changes | Changes in carotid artery resistance index,carotid intima-media thickness (CIMT). | 1 year |
| 12-items Short-Form Healthy Survey Questionnaire (SF-12) | Assesses health-related quality of life across two dimensions:Physical Component Summary (PCS) and Mental Component Summary (MCS). Typical Range: Both PCS and MCS scores usually fall within 40-60 (mean ±1 standard deviation). Low score (<40) indicates worse physical or mental health; High score (>60) indicates strong physical or mental health. | 1 year |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |