RecruitingPhase 4NCT05846490

Impact of Obstructive Sleep Apnea (OSA) Treatment on Blood Pressure Control in Chronic Kidney Disease

Impact of Obstructive Sleep Apnea Treatment on Blood Pressure Control in Chronic Kidney Disease: A Randomized Trial


Sponsor

University of Sao Paulo

Enrollment

150 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The role of obstructive sleep apnea (OSA) on chronic kidney disease (CKD) is not clear. This randomized clinical trial will test the impact of OSA treatment on blood pressure (BP) and on the estimated glomerular filtration rate (eGFR) in patients with CKD IIIb and IV (eGFR 44-15 ml/min). A polygraph will be performed to assess the presence of OSA (defined by an apnea-hypopnea index ≥15 events/hour). Patients with OSA will be randomized to use continuous positive upper airway pressure (CPAP) or to maintain optimized clinical treatment for BP control. Antihypertensive medication adjustments will be allowed using a standard protocol for both groups by the same researcher, who will not have access to CPAP follow-up. In addition to clinical (including BP and ambulatory BP monitoring, ABPM) and laboratory assessments at baseline, we will follow up at 3 months, 6 months, 9 months and 12 months after randomization of the proposed outcomes. Target organ damage analyses, such as the retina and echocardiography, will be performed at baseline and after 1 year of randomization. Primary objective: to compare the effect of CPAP on the need to adjust antihypertensive medication to control systolic BP (\<130mmHg) in patients with CKD; secondary objectives: 1) to evaluate the reduction in systolic and diastolic BP by office and ABPM; 2) assessment of nocturnal BP dipping; 3) to evaluate the impact of OSA treatment with CPAP on eGFR during follow-up; 4) to evaluate the impact of OSA treatment with CPAP on the evolution of albuminuria; 5) assessment of other target organ damage such as retinopathy and cardiac remodeling; 6) to evaluate the impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR \<15ml/min and dialysis); 7) to evaluate the impact of OSA treatment with CPAP on the quality of life of patients with CKD. With a significance level of 5% and study power of 90%, two-tailed hypothesis testing, 74 patients with OSA per group, i.e., 148 patients in total, will be required to assess the primary endpoint (we estimate that 25% and 50% of patients in control and CPAP groups will not need to adjust their antihypertensive medication at follow-up, respectively).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether treating obstructive sleep apnea (OSA) — a condition where breathing repeatedly stops during sleep — can help lower blood pressure in people who also have chronic kidney disease (CKD). **You may be eligible if...** - You have been diagnosed with both high blood pressure and chronic kidney disease (with reduced but not severely lost kidney function) - You have confirmed moderate-to-severe sleep apnea (diagnosed by a sleep study) - You are between 18 and 80 years old **You may NOT be eligible if...** - You are already on dialysis or have end-stage kidney disease - You have central sleep apnea (a different type from obstructive) - You already use CPAP or another sleep apnea treatment - You have had a recent heart attack, stroke, or major surgery - You are pregnant - You are unable or unwilling to use a CPAP device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECPAP

Continuous positive airway pressure + anti-hypertensive treatment intensification (if necessary)

DRUGUsual care

Anti-hypertensive treatment intensification (if necessary)


Locations(1)

Fernanda Trani Ferreira

São Paulo, Brazil

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NCT05846490


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