NCT06393036尚未招募不适用
The Effect of Obstructive Sleep Apnea on Severity and Prognosis of Patients With IgA Nephropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Acute kidney injury
研究概览
简要总结
This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with IgA nephropathy (IgAN), 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 IgAN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Acute kidney injury
时间窗: 2 years
次要结局
- Kidney dialysis rate(5 years)
- Rate of kidney failure(5 years)
研究者
Xiaowan Du
Principal Investigator
Peking University First Hospital
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