Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure

NCT ID: NCT01431157

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-10-31

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 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 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.

Conditions

Sleep Apnea; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasal oxygen

Nocturnal nasal oxygen

Group Type: ACTIVE_COMPARATOR

Nocturnal nasal oxygen

Intervention Type: PROCEDURE

Nasal oxygen at 2 l/min will be given at night

No nasal oxygen

Group Type: PLACEBO_COMPARATOR

No nasal oxygen

Intervention Type: OTHER

Patients will have no intervention for sleep apnea

Interventions

Nocturnal nasal oxygen

Nasal oxygen at 2 l/min will be given at night

Intervention Type: PROCEDURE

No nasal oxygen

Patients will have no intervention for sleep apnea

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• RDI > 15
• Symptomatic Heart failure
• Oxygen saturation < 88% during apnea
• Not currently be on nocturnal oxygen therapy, CPAP, or other PAP therapy

Exclusion Criteria

• Hypoxemia requiring oxygen supplementation
• serum creatinine > 2.5 or on chronic dialysis
• blood pressure > 160
• pregnant
• chronic physical disability that would prevent subjects from participating in any aspect of the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Stephen Gottlieb

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baltimore VA Medical Center

Baltimore, Maryland, United States

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00049080

Identifier Type: -

Identifier Source: org_study_id