CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

Study Overview
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Brief Summary
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All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr Echocardiography: It was performed initially to diagnose pulmonary hypertension and repeated after three months of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP. Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40 mmHg), moderate (41-55 mmHg), and severe (>55 mmHg) degrees. Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular systolic pressure (RVSP).

Official Title
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Impact of Continuous Positive Airway Pressure Therapy on Pulmonary Hypertension and Exercise Capacity in Newly Diagnosed Obstructive Sleep Apnea Patients

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Device: CPAP therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). Exclusion Criteria: Patients aged < 18 years Patients with secondary PH, due to pulmonary diseases, or left ventricular heart diseases , or chronic thromboembolic disorders. Patients on long term oxygen therapy (LTOT). Patients with respiratory neuromuscular weaknesses or chest wall deformities. End-organ failure and malignancies Obesity hypoventilation syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP ttt<br> | Device: CPAP therapy<br>* All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of mean pulmonary artery pressure measured by echo |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity improvement measured by six minute walking test |  | 3 months | 
| Exercise capacity improvement measured by maximun o2 consumption |  | 3 months |