A Phase 4 interventional study of CPAP and Nasal Strips in Obstructive Sleep Apnea and Pulmonary Edema Cardiac Cause, sponsored by University of Sao Paulo. Terminated at 4 sites in Brazil. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 150 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Continuous positive airway pressure
Device: CPAP
Nasal Strips
Device: Nasal Strips
This is the standard treatment for OSA.
Nasal strips were commercially available in the market for supposing treat snoring and sleep apnea but no proof that this is true. Our group previously validated nasal strips as an interesting placebo.
Rate of ACPE recurrence
To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo
Time frame: 1-year
Rate of all-cause mortality
To evaluate the effects of CPAP on the all-cause mortality as compared to placebo
Time frame: 1-year
Rate of cardiovascular mortality
To evaluate the effects of CPAP on the cardiovascular mortality as compared to placebo
Time frame: 1-year
Number of new hospital admissions
To evaluate the effects of CPAP on the number of new hospital admissions as compared to placebo
Time frame: 1-year
Blood pressure effects ( (mmHg)
To evaluate the effects of CPAP on the blood pressure reduction as compared to placebo
Time frame: 1-year
Levels of BNP levels (pg/ml)
To evaluate the effects of CPAP on the BNP levels as compared to placebo
Time frame: 1-year
Cardiac function (left ventricular ejection fraction - %)
To evaluate the effects of CPAP on the left ventricular ejection fraction (by echocardiography) as compared to placebo
Time frame: 1-year
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in Jul 2022, 39 months.
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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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