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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431157
Recruitment Status : Terminated (Poor enrollment)
First Posted : September 9, 2011
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland, College Park

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Heart Failure Procedure: Nocturnal nasal oxygen Other: No nasal oxygen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Study Start Date : November 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Nasal oxygen
Nocturnal nasal oxygen
Procedure: Nocturnal nasal oxygen
Nasal oxygen at 2 l/min will be given at night

Placebo Comparator: No nasal oxygen Other: No nasal oxygen
Patients will have no intervention for sleep apnea

Primary Outcome Measures :
  1. BNP (a blood test which is a biomarker for heart failure) [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431157

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United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore

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Responsible Party: Steve Gottlieb, Professor, University of Maryland, College Park Identifier: NCT01431157     History of Changes
Other Study ID Numbers: HP-00049080
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Keywords provided by Steve Gottlieb, University of Maryland, College Park:
Sleep Apnea Syndrome
Heart Failure
Oxygen Inhalation Therapy
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases