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Clinical Trials/NCT04769635
NCT04769635
Completed
Not Applicable

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

Zagazig University1 site in 1 country50 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Zagazig University
Enrollment
50
Locations
1
Primary Endpoint
change of mean pulmonary artery pressure measured by echo
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
October 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmad Abbas

Lecturer of chest diseases

Zagazig University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

change of mean pulmonary artery pressure measured by echo

Time Frame: 3 months

Secondary Outcomes

  • Exercise capacity improvement measured by maximun o2 consumption(3 months)
  • Exercise capacity improvement measured by six minute walking test(3 months)

Study Sites (1)

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