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

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Apr 30, 2024

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ClinConnect Summary

This clinical trial is studying how obstructive sleep apnea (OSA), a condition where breathing repeatedly stops and starts during sleep, affects the severity and outlook of patients with IgA nephropathy (IgAN), a kidney disease. The researchers want to see if using a machine called continuous positive airway pressure (CPAP), which helps keep the airways open during sleep, can improve health outcomes for these patients. Although the study will observe how patients choose to receive treatment, it aims to gather valuable information that can help doctors make better treatment decisions for people with both OSA and IgAN.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with IgAN based on specific medical tests and symptoms. They also need to have OSA confirmed through a sleep study showing a certain number of breathing interruptions per hour. However, those with other sleep disorders or serious health issues that could impact their sleep or kidney function won't be eligible. Participants will need to provide consent to join the study, and they can expect to undergo sleep monitoring and follow-up assessments throughout the trial. This study is not yet recruiting participants, but it aims to provide important insights into the relationship between these two conditions.

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Eligibility criteria

• Inclusion Criteria:
• • Diagnostic criteria: IgA nephropathy is diagnosed based on the pathological results of renal biopsy and/or clinical manifestations (such as hematuria, proteinuria, abnormal renal function, etc.), in accordance with the internationally recognized diagnostic criteria for IgA nephropathy. 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 (as both OSAHS and IgA nephropathy do not show significant gender predisposition).
• • 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.