Viewing Study NCT01431157



Ignite Creation Date: 2024-05-05 @ 11:51 PM
Last Modification Date: 2024-10-26 @ 10:40 AM
Study NCT ID: NCT01431157
Status: TERMINATED
Last Update Posted: 2022-03-10
First Post: 2011-09-07

Brief Title: Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Status: TERMINATED
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Poor enrollment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 57 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 intervention

The purpose of this study is to assess whether nocturnal oxygen administration via nasal cannula alone can improve outcomes in congestive heart failure patients with moderate to severe sleep apnea The effects of nocturnal oxygen administration will be assessed by using biomarkers of heart stress and markers of whole body inflammation
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None