The Outcome of Chronic Kidney Disease Patients With Obstructive Sleep Apnea Syndrome

Not yet recruiting

• Conditions: Chronic Kidney Diseases; OSAS (Obstructive Sleep Apneas Syndrome)

• Registration Number: NCT06971874
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Study Start: 2025-05-15
• Primary Completion: 2029-06-30
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• Voluntarily sign the informed consent form;

  • Aged ≥ 18 years and < 75 years;
  • Patients with CKD stages 3-4, with an eGFR of 15-60 ml/min/1.73m² calculated using the CKD-EPI formula for at least 3 months.

Exclusion Criteria

• Patients receiving oxygen therapy or continuous positive airway pressure (CPAP) treatment;

  • Patients with other sleep disorders, including restless legs syndrome, periodic limb movement disorder, etc.;
  • Patients with other severe comorbidities: Severe heart failure (NYHA class III or IV); Myocardial infarction, unstable angina, or stroke within the past 3 months; Severe arrhythmias requiring medication or device therapy; Respiratory diseases, including COPD, asthma, thoracic deformities, etc.; Neurological disorders, including myasthenia gravis, Parkinson's disease, Alzheimer's disease, etc.; Active liver disease or severe hepatic insufficiency; Psychiatric conditions, including depression, anxiety disorders, etc.; History of malignancy within the past 5 years (except cured basal cell carcinoma); Uncontrolled hyperthyroidism;
  • Patients who underwent surgery or had acute infections within the past 3 months;
  • Current heavy alcohol consumption:Females: >3 drinks/day or >7 drinks/week; Males: >4 drinks/day or >14 drinks/week (1 standard drink = 14g of alcohol)
  • Current use of medications that may severely interfere with sleep, such as antipsychotics, antiepileptics, antiparkinsonian drugs, antidepressants, opioids, etc.;
  • Females who are pregnant or lactating at screening or baseline;
  • Inability to comply with the study due to: Low education level, language barriers, inability to tolerate or complete sleep monitoring, or other reasons preventing completion of study procedures (e.g., follow-up);
  • Deemed unsuitable for participation by the investigator's judgment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Progression of Chronic Kidney Diseases in CKD Patients	six months	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 )
Renal death or Cardiovascular death	six months	Deaths Directly Caused by Renal or Cardiovascular Dysfunction or Their Acute or Chronic Complications

Secondary Outcome Measures

Name	Time	Method
24-hour urine protein(g/24h)	six months	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.
Rate of eGFR Decline(mL/min/1.73m²/year)	six months	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.
Doubling of Serum Creatinine	six months	A sustained ≥100% increase in serum creatinine(μmol/L) from baseline. Acute Kidney Injury: Occurring within 7 days. CKD progression: Over ≥3 months.
Cardiovascular Death	six months	Death due to cardiovascular events
All-Cause Death	six months	Death from any cause during the study period.
Cardiovascular Adverse Events	six months	Individual components of the MACE composite endpoint.
Major Adverse Cardiovascular Events(MACE)	six months	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.
Apnea-Hypopnea Index (AHI)	1 year	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.
Mean Blood Pressure(MBP, mmHg)	1 year	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).
Corrected QT Interval (QTc, ms)	1 year	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).
left ventricular ejection fraction (LVEF, %)	1 year	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%.
Carotid Ultrasound Measurement Changes	1 year	Changes in carotid artery resistance index,carotid intima-media thickness (CIMT).
12-items Short-Form Healthy Survey Questionnaire (SF-12)	1 year	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.