- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368171
Role of Heme-oxygenase (HO) and Nitric Oxide (NO) Pathway in Patients With Obstructive Sleep Apnea (OSA) and Pulmonary Hypertension (PH)
Research design: This is a controled prospective study.
Methodology:
Patients with newly diagnosed and untreated OSA with total apnea-hypopnea index (AHI) >5/h, and control (AHI<5/h) will be recruited from the Long Beach VA sleep center. Controls are subjects without OSA or other sleep disorders and no sign of pulmonary hypertension based on echo. The investigators also measure pulmonary artery pressure by 2D Echo and exclude patient with any sign of left heart dysfunction. PH will be defined as RVSP > 35 mmHg or mean PA pressure>25 mmHg. The investigators will recruit subjects with and without PH and OSA in three separate groups:
- group one : OSA+ PH,
- group two: normal individual with no OSA and no PH,
- group three: OSA with no PH Pulmonary function test will be done to exclude patients with underlying lung disease.
The inclusion criteria is: Age >20, AHI >5, AHI <5 (as control), RVSP > 35 mmHg OR Mean PA pressure>25 mmHg, RVSP < 35 mmHg OR Mean PA pressure < 25 mmHg (as control).
Subjects will be excluded if they had known peripheral vascular disease, liver disease, hemolytic anemia, inflammatory disease, active infection, or if they were pregnant, on therapy for OSA, on chronic steroid treatment, or younger than 20 years of age, patients with left heart failure (systolic or diastolic), patients are on PH medications including sildenafil, active smokers, COPD and asthma, active infection or inflammatory disease and collagen vascular disease.
Nocturnal polysomnography will be performed and scored according to the American Academy of Sleep Medicine.
Exhaled Carbon monoxide (CO) will be measured with a calibrated fuel cell type electrochemical device with sensor sensitivity of 1 ppm. The mean of three reproducible measurements will be recorded and corrected for ambient CO.
Exhaled Nitric Oxide (NO) will be measured. At each testing session, at least three flow-regulated FENO measurements will be performed.
The investigators will repeat 2D Echo and measurements of above factors after 3 months of CPAP treatment. The investigators also check patient's compliance with the treatment by downloading data off of their CPAP device.
Each subject will be informed of the experimental procedures, which is approved by the Human Investigation Committee of the VA-Long Beach.
Finding:
The investigators hypothesize that HO pathway causing perturbation of pulmonary endothelial function by inhibition of nitric oxide.
Clinical significance:
OSA is associated with PH, but exact mechanism is not well known. In the past, I have shown that increased endogenous CO in the setting of elevated NO concentration is associated with endothelial dysfunction in patient with OSA. Therefore, the investigators sought to investigate the roles of HO and NO pathways in patients with OSA associated with PH.
Impact/significance:
It addresses a fundamental gap in our understanding of how OSA results in increase the pulmonary artery pressure and if substantiated, will provide the basis for the design and testing of new approaches to prevention and treatment of OSA.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with newly diagnosed and untreated OSA with total apnea-hypopnea index (AHI) >5/h, and control (AHI<5/h) will be recruited from the Long Beach VA sleep center. Controls are subjects without OSA or other sleep disorders and no sign of pulmonary hypertension based on echo. We also measure pulmonary artery pressure by 2D Echo and exclude patient with any sign of left heart dysfunction. PH will be defined as RVSP > 35 mmHg or mean PA pressure>25 mmHg. We will recruit subjects with and without PH and OSA in three separate groups:
- group one : OSA+ PH,
- group two: normal individual with no OSA and no PH,
- group three: OSA with no PH Pulmonary function test will be done to exclude patients with underlying lung disease.
Description
Inclusion Criteria:
- participants must satisfy diagnostic criteria for Obstructive sleep apnea.
- evidence of pulmonary hypertension disease base upon one or more of the following: RVSP > 35 mmHg OR Mean PA pressure>25 mmHg, RVSP < 35 mmHg OR Mean PA pressure < 25 mmHg (as control).
- age greater than or equal to 20 years.
- no significant alcohol use (7 or fewer drinks per week).
Exclusion Criteria:
- peripheral vascular disease
- liver disease
- Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
- Any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
- hemolytic anemia
- inflammatory disease
- active infection,
- on therapy for OSA,
- on chronic steroid treatment,
- younger than 20 years of age,
- patients with left heart failure (systolic or diastolic),
- patients are on pulmonary hypertension medications including sildenafil,
- active smokers,
- COPD and asthma,
- active infection or inflammatory disease
- collagen vascular disease.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obstructive sleep apnea with pulmonary hypertension
Patients with AHI> 5/h and pulmonary hypertension with RVSP>35 mmHg on Echo
|
|
control
patients with AHI<5/h and RVSP<35 mmHg on Echo
|
|
OSA with no Pulmonary hypertension
patients with AHI>5/h, but RVSP<35 mmHg on Echo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exhaled carbon monxide and nitric oxide
Time Frame: 3 month
|
The concentration of both gas will be measured in PPM and will be repeated in 3 month after CPAP is being used.
|
3 month
|
RVSP as sorrogate of Pulmonary artery pressure
Time Frame: 3 month
|
It will be measured by 2D-Echo in mmHg and correlation of RVSP and above two gases will be assessed.
|
3 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Lung Diseases
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Hypertension
- Hypertension, Pulmonary
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antimetabolites
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
- Carbon Monoxide
Other Study ID Numbers
- OSA-PH-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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