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临床试验/NCT02368171
NCT02368171Unknown不适用

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

Southern California Institute for Research and Education0 个研究点目标入组 60 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
exhaled carbon monxide and nitric oxide

研究概览

简要总结

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. 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

exhaled carbon monxide and nitric oxide

时间窗: 3 month

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

RVSP as sorrogate of Pulmonary artery pressure

时间窗: 3 month

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Behrouz Jafari

Assisstant professore of medicine

Southern California Institute for Research and Education

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