Effect of treating sleep apnea on blood pressure in kidney disease patients
Impact of Obstructive Sleep Apnea Treatment on Blood Pressure Control in Chronic Kidney Disease: A Randomized Trial
This study is testing if treating sleep apnea can help lower blood pressure and improve kidney health in people with chronic kidney disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05846490 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how treating obstructive sleep apnea (OSA) affects blood pressure and kidney function in patients with chronic kidney disease (CKD) stages IIIb and IV. Participants diagnosed with hypertension and confirmed OSA will be randomly assigned to receive either continuous positive airway pressure (CPAP) therapy or standard care for blood pressure management. The study will monitor various clinical and laboratory outcomes over a 12-month period, including blood pressure readings and kidney function assessments. The aim is to determine if OSA treatment can improve blood pressure control and kidney health in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic kidney disease stages IIIb or IV who also have a confirmed diagnosis of hypertension and obstructive sleep apnea.
Not a fit: Patients with severe asthma, chronic obstructive pulmonary disease, or those currently receiving treatment for obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management and kidney function in patients with chronic kidney disease and obstructive sleep apnea.
How similar studies have performed: Previous studies have shown promising results in managing blood pressure through OSA treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of hypertension: Use of oral antihypertensive drugs or systolic BP (SBP) \>140 mmHg and/or diastolic BP (DBP) \>90 mmHg on 2 office measurements or \>130x80 mmHg (24 hours ABPM). * eGFR by the CKD-EPI equation between 45 ml/min/1.73m2 and 15 ml/min/1.73m2 (in conservative treatment of CKD). Exclusion Criteria: * Professional drivers; * Home supplemental oxygen users; * Patients under current treatment for OSA; * Pregnant women; * Patients with malignant neoplasms or terminal illnesses; * Severe asthma or chronic obstructive pulmonary disease; * Patients with systemic lupus erythematosus, amyloidosis or systemic sclerosis; * Patients with a history of solid organ transplants.
Where this trial is running
São Paulo
- Fernanda Trani Ferreira — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Luciano Drager, MD, PhD — University of Sao Paulo
- Study coordinator: Luciano Drager, MD, PhD
- Email: luciano.drager@incor.usp.br
- Phone: 5511-26617686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.