NCT01431157

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

1.9 years

First QC Date

September 7, 2011

Last Update Submit

February 23, 2022

Conditions

Sleep ApneaHeart Failure

Keywords

Sleep Apnea SyndromeHeart FailureOxygen Inhalation Therapy

Outcome Measures

Primary Outcomes (1)

  • BNP (a blood test which is a biomarker for heart failure)

    1 month

Study Arms (2)

Nasal oxygen

ACTIVE COMPARATOR

Nocturnal nasal oxygen

Procedure: Nocturnal nasal oxygen

No nasal oxygen

PLACEBO COMPARATOR
Other: No nasal oxygen

Interventions

Nocturnal nasal oxygenPROCEDURE

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

Nasal oxygen
No nasal oxygenOTHER

Patients will have no intervention for sleep apnea

No nasal oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesHeart Failure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 9, 2011

Study Start

November 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 10, 2022

Record last verified: 2022-02

Locations

US(2)