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

This study has been terminated.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Steve Gottlieb, University of Maryland
ClinicalTrials.gov Identifier:
NCT01431157
First received: September 7, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Sleep Apnea
Heart Failure
Procedure: Nocturnal nasal oxygen
Other: No nasal oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • BNP (a blood test which is a biomarker for heart failure) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431157

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

No publications provided

Responsible Party: Steve Gottlieb, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01431157     History of Changes
Other Study ID Numbers: HP-00049080
Study First Received: September 7, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Sleep Apnea Syndrome
Heart Failure
Oxygen Inhalation Therapy

Additional relevant MeSH terms:
Heart Failure
Apnea
Sleep Apnea Syndromes
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014