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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Luciano Drager, MD, PhD contact

5511-26617686

luciano.drager@incor.usp.br

Fernanda Trani Ferreira, MD contact

5511-26617686

tranifernanda@gmail.com

Brazil1 site, 1 recruiting
  • Fernanda Trani Ferreira

    São Paulo

    Fernanda Trani Ferreira, MD, 5511-26617686, tranifernanda@gmail.com

    Recruiting

Other trials in Brazil

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).

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 groups in NCT05846490
Study groupRoleWhat they receive
Continuous positive airway pressure (CPAP)ExperimentalStandard OSA treatment + BP adjustments with anti-hypertensive therapy
Receives: Device: CPAP
Usual CareActive comparatorBP 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.

  1. Anti-hypertensive intensification

    Percentage of patients that required treatment modification aiming at blood pressure control

    Measured: 1 year

Secondary outcomes (7)
  1. Systolic and diastolic blood pressure change by office measurement and ambulatory blood pressure monitoring

    Absolute blood pressure change

    Measured: 1 year

  2. Nocturnal blood pressure dipping

    Assessment of nocturnal blood pressure dipping using ambulatory blood pressure monitoring

    Measured: 1 year

  3. Estimated glomerular filtration rate (eGFR)

    Impact of OSA treatment with CPAP on eGFR

    Measured: 1 year

  4. Albuminuria

    Impact of OSA treatment with CPAP on the evolution of albuminuria

    Measured: 1 year

  5. 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

  6. 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

  7. 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.

  1. First posted6 May 2023
  2. Study start8 Jan 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

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)
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

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.

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