NCT02368171

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

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Status
unknown

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

February 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

February 9, 2015

Last Update Submit

February 12, 2015

Conditions

Obstructive Sleep ApneaPulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 month

  • 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.

    3 month

Study Arms (3)

Obstructive sleep apnea with pulmonary hypertension

Patients with AHI\> 5/h and pulmonary hypertension with RVSP\>35 mmHg on Echo

Other: measure exhaled carbon monoxide and nitric oxide

control

patients with AHI\<5/h and RVSP\<35 mmHg on Echo

Other: measure exhaled carbon monoxide and nitric oxide

OSA with no Pulmonary hypertension

patients with AHI\>5/h, but RVSP\<35 mmHg on Echo

Other: measure exhaled carbon monoxide and nitric oxide

Interventions

measure exhaled carbon monoxide and nitric oxideOTHER
OSA with no Pulmonary hypertensionObstructive sleep apnea with pulmonary hypertensioncontrol

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension, Pulmonary

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesLung DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professore of medicine

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 20, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Last Updated

February 20, 2015

Record last verified: 2015-02