Sleep ApneaPhase 4NCT05846490
Impact of Obstructive Sleep Apnea (OSA) Treatment on Blood Pressure Control in Chronic Kidney Disease
A Phase 4 study testing CPAP in people with Sleep Apnea and Chronic Kidney Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Chronic Kidney Diseases
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jan 2024to May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Fernanda Trani Ferreira
São Paulo
Fernanda Trani Ferreira, MD, 5511-26617686, tranifernanda@gmail.com
About this study
Official title: Impact of Obstructive Sleep Apnea Treatment on Blood Pressure Control in Chronic Kidney Disease: A Randomized Trial
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).
- Conditions
- Sleep Apnea, Chronic Kidney Diseases
- Being tested
- CPAP, Usual care
- Medical subject headings
- Sleep Apnea Syndromes, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Continuous positive airway pressure + anti-hypertensive treatment intensification (if necessary)
Usual careDrug
Anti-hypertensive treatment intensification (if necessary)
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure (CPAP) | Experimental | Standard OSA treatment + BP adjustments with anti-hypertensive therapy Receives: Device: CPAP |
| Usual Care | Active comparator | BP adjustments with anti-hypertensive therapy Receives: Drug: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-hypertensive intensification
Percentage of patients that required treatment modification aiming at blood pressure control
Measured: 1 year
Secondary outcomes (7)
Systolic and diastolic blood pressure change by office measurement and ambulatory blood pressure monitoring
Absolute blood pressure change
Measured: 1 year
Nocturnal blood pressure dipping
Assessment of nocturnal blood pressure dipping using ambulatory blood pressure monitoring
Measured: 1 year
Estimated glomerular filtration rate (eGFR)
Impact of OSA treatment with CPAP on eGFR
Measured: 1 year
Albuminuria
Impact of OSA treatment with CPAP on the evolution of albuminuria
Measured: 1 year
Target organ damage using echocardiogram and fundoscopy
Impact of OSA treatment with CPAP on target organ damage such as grade of retinopathy and cardiac remodeling (left ventricular mass index, diastolic dysfunction, etc. by echocardiography).
Measured: 1 year
End-stage renal disease (need of dialysis)
Impact of OSA treatment with CPAP on the possible delay for renal replacement therapy or end-stage renal disease (eGFR <15ml/min)
Measured: 1 year
Continuous analysis of Quality of life
Impact of OSA treatment with CPAP on the quality of life (measured by 36-Item Short Form Health Survey). The lowest and highest possible scores are 0 and 100, respectively. The lower the score the higher impairment in quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start8 Jan 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano F Drager, MD, PhD, University of Sao Paulo
- Investigators
- Luciano Drager, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846490
- Sponsor's protocol ID
- 64401922.8.0000.0068
- Status last verified
- Jun 2024
- First submitted
- 14 Apr 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obstructive Sleep Apnea Treatment on Blood Pressure Control in Chronic Kidney Disease: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05846490
- Acronym / sponsor ID
- 64401922.8.0000.0068
- Conditions
- Sleep Apnea, Chronic Kidney Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure (CPAP) | Experimental | Device: CPAPStandard OSA treatment + BP adjustments with anti-hypertensive therapy |
| Usual Care | Active comparator | Drug: Usual careBP adjustments with anti-hypertensive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (8 listed)
- Professional drivers;
- Home supplemental oxygen users;
- Patients under current treatment for OSA;
- Pregnant women;
- Patients with malignant neoplasms or terminal illnesses;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPContinuous positive airway pressure + anti-hypertensive treatment intensification (if necessary) | Device | Continuous positive airway pressure (CPAP) |
| Usual careAnti-hypertensive treatment intensification (if necessary) | Drug | Usual Care |
Primary outcome
Anti-hypertensive intensification
Time frame: 1 year
Percentage of patients that required treatment modification aiming at blood pressure control
7 secondary outcomes
Systolic and diastolic blood pressure change by office measurement and ambulatory blood pressure monitoring
Time frame: 1 year
Nocturnal blood pressure dipping
Time frame: 1 year
Estimated glomerular filtration rate (eGFR)
Time frame: 1 year
Albuminuria
Time frame: 1 year
Target organ damage using echocardiogram and fundoscopy
Time frame: 1 year
End-stage renal disease (need of dialysis)
Time frame: 1 year
Continuous analysis of Quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Drager, MD, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP in people with Sleep Apnea and Chronic Kidney Diseases, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luciano Drager, MD, PhD (5511-26617686, luciano.drager@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-hypertensive intensification (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.