Clinical trial NCT06393036: The Effect of OSA on Severity and Prognosis of Patients With IgAN
Official title: The Effect of Obstructive Sleep Apnea on Severity and Prognosis of Patients With IgA Nephropathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
IgA Nephropathy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with both OSA and IgAN

Brief summary: 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.


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.

Primary outcomes:
measure: Acute kidney injury
timeFrame: 2 years
Secondary outcomes:
measure: Rate of kidney failure
timeFrame: 5 years
measure: Kidney dialysis rate
timeFrame: 5 years
Other outcomes:
measure: change in serum creatinine
timeFrame: 2 years
measure: change in serum eGFR
timeFrame: 2 years
measure: change in blood urea nitrogen
timeFrame: 2 years
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Xiaowan Du
role: STUDY_DIRECTOR
References: