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NCT01431157 · ClinicalTrials.gov registry record · NA
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
A NA study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01431157 is a NA study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 20 participants.
The verdict
NCT01431157, a NA study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias, pulmonary hypertension, heart failure, and premature death. There is significant evidence suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of the abnormalities associated with this disease. Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild sleep apnea is present in 17% of adults in the general population and moderate to severe sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to be anywhere from 11-53% in heart failure patients. Continuous positive airway pressure (CPAP) therapy is currently the standard of care for sleep apnea sufferers regardless of the severity of their disease. In patients without heart failure, CPAP therapy has numerous benefits and several long term studies have reported that CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular symptoms and mortality among patient with severe sleep apnea. In heart failure patients, CPAP has shown some beneficial short term effects but evidence of long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is often poor and many people cannot tolerate it. This further limits the therapeutic effectiveness of this interve
Interventions
- PROCEDURE Nocturnal nasal oxygen
- OTHER No nasal oxygen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-11 |
| Est. Completion | 2013-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01431157
The ClinicalTrials.gov registry entry for NCT01431157 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nocturnal nasal oxygen is the first listed.
NCT01431157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01431157 about?
NCT01431157 is a clinical study titled "Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure". Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disea...
What is the current status of trial NCT01431157?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2011-11. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01431157?
The interventions under investigation include: Nocturnal nasal oxygen (PROCEDURE), No nasal oxygen (OTHER).
Who is sponsoring clinical trial NCT01431157?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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