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

The Epidemiological Patterns of Obstructive Sleep Apnea Syndrome in Patients With Chronic Kidney Disease and Its Impact on Renal Prognosis

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases; OSAS (Obstructive Sleep Apneas Syndrome)
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 356

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 518000
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: min liang; Phone Number: 020-6287120; Email: nfyylm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from department of Nephrology, Nanfang Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronic kidney diseases with OSA	Other: No intervention; No intervention
chronic kidney diseases without OSA	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 14, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Renal Insufficiency; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Renal Insufficiency, Chronic
• Other Study ID Numbers: NFEC-2025-081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No