Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Primary Purpose
Sleep Apnea, Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nocturnal nasal oxygen
No nasal oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring Sleep Apnea Syndrome, Heart Failure, Oxygen Inhalation Therapy
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
Sites / Locations
- Baltimore VA Medical Center
- University of Maryland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nasal oxygen
No nasal oxygen
Arm Description
Nocturnal nasal oxygen
Outcomes
Primary Outcome Measures
BNP (a blood test which is a biomarker for heart failure)
Secondary Outcome Measures
Full Information
NCT ID
NCT01431157
First Posted
September 7, 2011
Last Updated
February 23, 2022
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01431157
Brief Title
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Official Title
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Heart Failure
Keywords
Sleep Apnea Syndrome, Heart Failure, Oxygen Inhalation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal oxygen
Arm Type
Active Comparator
Arm Description
Nocturnal nasal oxygen
Arm Title
No nasal oxygen
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Nocturnal nasal oxygen
Intervention Description
Nasal oxygen at 2 l/min will be given at night
Intervention Type
Other
Intervention Name(s)
No nasal oxygen
Intervention Description
Patients will have no intervention for sleep apnea
Primary Outcome Measure Information:
Title
BNP (a blood test which is a biomarker for heart failure)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure
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