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NCT Number: NCT06971874

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

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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Key information

Conditions

Chronic Kidney Diseases Apnea Chronic Disease Disease Attributes Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases OSAS (Obstructive Sleep Apneas Syndrome) Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 518000, China

Location status: Recruiting

Location contact

min liang

CONTACT

[email protected]

020-6287120

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. The Progression of Chronic Kidney Diseases in CKD Patients

    Time frame: 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 )

  2. Renal death or Cardiovascular death

    Time frame: six months

    Deaths Directly Caused by Renal or Cardiovascular Dysfunction or Their Acute or Chronic Complications

Secondary outcomes

  1. Major Adverse Cardiovascular Events(MACE)

    Time frame: 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.

  2. Cardiovascular Adverse Events

    Time frame: six months

    Individual components of the MACE composite endpoint.

  3. 24-hour urine protein(g/24h)

    Time frame: 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.

  4. Rate of eGFR Decline(mL/min/1.73m²/year)

    Time frame: 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.

  5. Doubling of Serum Creatinine

    Time frame: 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.

  6. Cardiovascular Death

    Time frame: six months

    Death due to cardiovascular events

  7. All-Cause Death

    Time frame: six months

    Death from any cause during the study period.

  8. Apnea-Hypopnea Index (AHI)

    Time frame: 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.

  9. Mean Blood Pressure(MBP, mmHg)

    Time frame: 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).

  10. Corrected QT Interval (QTc, ms)

    Time frame: 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).

  11. left ventricular ejection fraction (LVEF, %)

    Time frame: 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%.

  12. Carotid Ultrasound Measurement Changes

    Time frame: 1 year

    Changes in carotid artery resistance index,carotid intima-media thickness (CIMT).

  13. 12-items Short-Form Healthy Survey Questionnaire (SF-12)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 14, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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