Menu
Recruiting NCT06971874

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

— Observational Chronic Kidney Diseases OSAS (Obstructive Sleep Apneas Syndrome)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, OSAS (Obstructive Sleep Apneas Syndrome). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • The Progression of Chronic Kidney Diseases in CKD Patients [Time frame: six months]
  • Renal death or Cardiovascular death [Time frame: six months]
Secondary outcome measures (12)
  • Major Adverse Cardiovascular Events(MACE) [Time frame: six months]
  • Cardiovascular Adverse Events [Time frame: six months]
  • 24-hour urine protein(g/24h) [Time frame: six months]
  • Rate of eGFR Decline(mL/min/1.73m²/year) [Time frame: six months]
  • Doubling of Serum Creatinine [Time frame: six months]
  • Cardiovascular Death [Time frame: six months]
  • All-Cause Death [Time frame: six months]
  • Apnea-Hypopnea Index (AHI) [Time frame: 1 year]
  • Mean Blood Pressure(MBP, mmHg) [Time frame: 1 year]
  • Corrected QT Interval (QTc, ms) [Time frame: 1 year]
  • left ventricular ejection fraction (LVEF, %) [Time frame: 1 year]
  • Carotid Ultrasound Measurement Changes [Time frame: 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Identifiers

NCT: NCT06971874 · NFEC-2025-081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗