The Effect of OSA on Severity and Prognosis of Patients With CKD

Obstructive Sleep Apnea Clinical Trial

Official title:

The Effect of Obstructive Sleep Apnea on Severity and Prognosis of Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393023
• Other study ID #: PekingUFH ENT OSACKD V1.0
• Status: Not yet recruiting
• Start date: July 15, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Peking University First Hospital
• Contact: Xiaowan Du
• Phone: 13552834319
• Email: xiaowandu26[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with chronic kidney disease (CKD), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and CKD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnostic criteria: Chronic kidney disease is diagnosed based on clinical manifestations (such as hematuria, proteinuria, abnormal renal function, etc.), in accordance with the internationally recognized diagnostic criteria. Obstructive sleep apnea-hypopnea syndrome (OSAHS) is confirmed through overnight polysomnography (PSG) with an apnea-hypopnea index (AHI) of =5 events per hour, primarily consisting of obstructive events.

• Age and gender: Participants must be =18 years old, with no gender restrictions.

• Informed consent: Participants are required to voluntarily sign a written informed consent form, acknowledging and agreeing to participate in the study, including all its contents and potential risks.

Exclusion Criteria:

• Other sleep-related breathing disorders: Participants with mixed sleep apnea, central sleep apnea, or severe snoring with an AHI index of <5 events per hour will be excluded to ensure that the study population is limited to patients with OSAHS.

• Severe internal medical conditions: Patients with severe cardiopulmonary dysfunction, malignancy, severe liver disease, mental disorders, or other severe internal medical conditions that may significantly affect sleep or the progression of kidney disease will be excluded.

• Recent surgery or medication: Individuals who have undergone surgery within the past 3 months that may affect sleep or kidney function, or who are currently using medications that may significantly interfere with sleep or the assessment of kidney disease (such as corticosteroids, immunosuppressants, novel antipsychotics, etc.) will be excluded.

• Pregnant women.

• Inability to cooperate with the study: Patients who are unable to complete the study procedures (including polysomnography, follow-up, etc.) due to cognitive impairment, language communication difficulties, remote residence, or other reasons will be excluded.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Obstructive Sleep Apnea
• Renal Insufficiency, Chronic
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
Although this study is designed as an observational cohort study, where patients were not assigned to intervention or non-intervention groups, there is still an intervention project indicator present in the observational cohort. The intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. CPAP is a commonly used therapy for obstructive sleep apnea (OSA) and other sleep-related breathing disorders. The principle of CPAP treatment lies in maintaining a constant airway pressure during sleep to prevent the collapse of the upper airway and ensure unobstructed breathing. The patient wears a mask connected to a CPAP machine, which generates a steady stream of air to provide the necessary pressure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in serum creatinine		2 years
Other	change in serum eGFR		2 years
Other	change in blood urea nitrogen		2 years
Primary	Acute kidney injury		2 years
Secondary	Rate of kidney failure		5 years
Secondary	Kidney dialysis rate		5 years