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

NCT06393036 | Not Yet Recruiting FDA Device

• 1 other identifier: PekingUFH ENT OSAIgAN V1.0
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea; IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  2 years

Secondary Outcomes (2)

• Rate of kidney failure

  5 years

• Kidney dialysis rate

  5 years

Other Outcomes (3)

• change in serum creatinine

  2 years

• change in serum eGFR

  2 years

• change in blood urea nitrogen

  2 years

Study Arms (1)

Patients diagnosed with both OSA and IgAN

Patients diagnosed with both OSA and IgAN, and treated with CPAP in addition to nephrological drug therapy or not.

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

The intervention in this study involves the use of Continuous Positive Airway Pressure (CPAP) treatment. 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. 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.

Patients diagnosed with both OSA and IgAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with both OSA and IgAN

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Glomerulonephritis, IGA

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Xiaowan Du

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaowan Du

CONTACT

13552834319; xiaowandu26@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 1, 2024
• Study Start: July 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share