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

February 23, 2022 updated by: Stephen Gottlieb, University of Maryland, Baltimore

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BNP (a blood test which is a biomarker for heart failure)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00049080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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