Clinical trial NCT06971874: The Outcome of Chronic Kidney Disease Patients With Obstructive Sleep Apnea Syndrome
Official title: The Epidemiological Patterns of Obstructive Sleep Apnea Syndrome in Patients With Chronic Kidney Disease and Its Impact on Renal Prognosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Diseases
OSAS (Obstructive Sleep Apneas Syndrome)
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be recruited from department of Nephrology, Nanfang Hospital

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.


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.

Primary outcomes:
measure: The Progression of Chronic Kidney Diseases in CKD Patients
timeFrame: six months
measure: Renal death or Cardiovascular death
timeFrame: six months
Secondary outcomes:
measure: Major Adverse Cardiovascular Events(MACE)
timeFrame: six months
measure: Cardiovascular Adverse Events
timeFrame: six months
measure: 24-hour urine protein(g/24h)
timeFrame: six months
measure: Rate of eGFR Decline(mL/min/1.73m²/year)
timeFrame: six months
measure: Doubling of Serum Creatinine
timeFrame: six months
measure: Cardiovascular Death
timeFrame: six months
measure: All-Cause Death
timeFrame: six months
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 1 year
measure: Mean Blood Pressure(MBP, mmHg)
timeFrame: 1 year
measure: Corrected QT Interval (QTc, ms)
timeFrame: 1 year
measure: left ventricular ejection fraction (LVEF, %)
timeFrame: 1 year
measure: Carotid Ultrasound Measurement Changes
timeFrame: 1 year
measure: 12-items Short-Form Healthy Survey Questionnaire (SF-12)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: