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

NCT06971874 | Recruiting

• 1 other identifier: NFEC-2025-081
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; OSAS (Obstructive Sleep Apneas Syndrome)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Major Adverse Cardiovascular Events(MACE)

  six months

• Cardiovascular Adverse Events

  six months

• 24-hour urine protein(g/24h)

  six months

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

  six months

• Doubling of Serum Creatinine

  six months

Study Arms (2)

chronic kidney diseases with OSA

Other: No intervention

chronic kidney diseases without OSA

Other: No intervention

Interventions

No intervention OTHER

No intervention

chronic kidney diseases with OSA; chronic kidney diseases without OSA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: May 14, 2025
• Study Start: July 17, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)