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Obstructive Sleep ApneaNCT02368171

Role of Heme-oxygenase (HO) and Nitric Oxide (NO) Pathway in Patients With Obstructive Sleep Apnea (OSA) and Pulmonary Hypertension (PH)

An observational study of Obstructive Sleep Apnea and Pulmonary Hypertension, run by Southern California Institute for Research and Education.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
measure exhaled carbon monoxide and nitric oxide
How many people
60 participants
Where
No sites listed yet
Study dates
Mar 2015to Mar 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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: 1. group one : OSA+ PH, 2. group two: normal individual with no OSA and no PH, 3. group three: OSA with no PH Pulmonary function test will be done to exclude patients with underlying lung disease.

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

About this study

Research design: This is a controled prospective study.

Methodology:

Read more

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:

  1. group one : OSA+ PH,
  2. group two: normal individual with no OSA and no PH,
  3. 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.

Being tested
measure exhaled carbon monoxide and nitric oxide
Medical subject headings
Sleep Apnea, Obstructive, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measure exhaled carbon monoxide and nitric oxideOther

Study groups in NCT02368171
Study groupRoleWhat they receive
Obstructive sleep apnea with pulmonary hypertensionPatients with AHI> 5/h and pulmonary hypertension with RVSP>35 mmHg on Echo
Receives: Other: measure exhaled carbon monoxide and nitric oxide
controlpatients with AHI<5/h and RVSP<35 mmHg on Echo
Receives: Other: measure exhaled carbon monoxide and nitric oxide
OSA with no Pulmonary hypertensionpatients with AHI>5/h, but RVSP<35 mmHg on Echo
Receives: Other: measure exhaled carbon monoxide and nitric oxide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. exhaled carbon monxide and nitric oxide

    The concentration of both gas will be measured in PPM and will be repeated in 3 month after CPAP is being used.

    Measured: 3 month

  2. RVSP as sorrogate of Pulmonary artery pressure

    It will be measured by 2D-Echo in mmHg and correlation of RVSP and above two gases will be assessed.

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02368171
Sponsor's protocol ID
OSA-PH-001
Status last verified
Feb 2015
First submitted
9 Feb 2015
Last updated
20 Feb 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea and Pulmonary Hypertension, run by Southern California Institute for Research and Education.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

exhaled carbon monxide and nitric oxide (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2015.

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