Health TrialsbyHealthPanel

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

ConditionsChronic Kidney DiseasesOSAS (Obstructive Sleep Apneas Syndrome)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

356 Participants
are divided into 2 treatment groups
Group A: chronic kidney diseases with OSA1 intervention
Group B: chronic kidney diseases without OSA1 intervention

Trial outcomes

Primary outcomes

1

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 )

Time frame
six months
2

Renal death or Cardiovascular death

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

Time frame
six months

Secondary outcomes

1

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.

Time frame
six months
2

Cardiovascular Adverse Events

Individual components of the MACE composite endpoint.

Time frame
six months
3

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.

Time frame
six months
4

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.

Time frame
six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov
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