Chronic Kidney DiseasesNCT06971874
The Outcome of Chronic Kidney Disease Patients With Obstructive Sleep Apnea Syndrome
An observational study of Chronic Kidney Diseases and OSAS (Obstructive Sleep Apneas Syndrome), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, OSAS (Obstructive Sleep Apneas Syndrome)
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be recruited from department of Nephrology, Nanfang Hospital
Who may be able to join
- 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.
Who cannot join
- 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.;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 518000
min liang, 020-6287120, nfyylm@163.com
About this study
Official title: The Epidemiological Patterns of Obstructive Sleep Apnea Syndrome in Patients With Chronic Kidney Disease and Its Impact on Renal Prognosis
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.
- Being tested
- No intervention
- Medical subject headings
- Renal Insufficiency, Chronic, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| chronic kidney diseases with OSA | Not described Receives: Other: No intervention | |
| chronic kidney diseases without OSA | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: six months
Renal death or Cardiovascular death
Deaths Directly Caused by Renal or Cardiovascular Dysfunction or Their Acute or Chronic Complications
Measured: six months
Secondary outcomes (13)
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.
Measured: six months
Cardiovascular Adverse Events
Individual components of the MACE composite endpoint.
Measured: six months
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.
Measured: six months
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.
Measured: six months
Doubling of Serum Creatinine
A sustained ≥100% increase in serum creatinine(μmol/L) from baseline. Acute Kidney Injury: Occurring within 7 days. CKD progression: Over ≥3 months.
Measured: six months
Cardiovascular Death
Death due to cardiovascular events
Measured: six months
All-Cause Death
Death from any cause during the study period.
Measured: six months
Apnea-Hypopnea Index (AHI)
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.
Measured: 1 year
Mean Blood Pressure(MBP, mmHg)
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).
Measured: 1 year
Corrected QT Interval (QTc, ms)
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).
Measured: 1 year
left ventricular ejection fraction (LVEF, %)
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%.
Measured: 1 year
Carotid Ultrasound Measurement Changes
Changes in carotid artery resistance index,carotid intima-media thickness (CIMT).
Measured: 1 year
12-items Short-Form Healthy Survey Questionnaire (SF-12)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start17 Jul 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971874
- Sponsor's protocol ID
- NFEC-2025-081
- Status last verified
- Nov 2025
- First submitted
- 20 Mar 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiological Patterns of Obstructive Sleep Apnea Syndrome in Patients With Chronic Kidney Disease and Its Impact on Renal Prognosis
- ClinicalTrials.gov ID
- NCT06971874
- Acronym / sponsor ID
- NFEC-2025-081
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic kidney diseases with OSA | – | Other: No intervention |
| chronic kidney diseases without OSA | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from department of Nephrology, Nanfang Hospital
Key inclusion criteria (3 listed)
- Voluntarily sign the informed consent form;
Key exclusion criteria (9 listed)
- Patients receiving oxygen therapy or continuous positive airway pressure (CPAP) treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | chronic kidney diseases with OSA, chronic kidney diseases without OSA |
Primary outcome
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 )
Renal death or Cardiovascular death
Time frame: six months
Deaths Directly Caused by Renal or Cardiovascular Dysfunction or Their Acute or Chronic Complications
13 secondary outcomes
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
12-items Short-Form Healthy Survey Questionnaire (SF-12)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and OSAS (Obstructive Sleep Apneas Syndrome), run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Progression of Chronic Kidney Diseases in CKD Patients (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.