CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769635
• Other study ID #: ZU-IRB#5654
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: February 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP therapy
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

Locations

Country	Name	City	State
Egypt	Ahmad Abbas	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of mean pulmonary artery pressure measured by echo		3 months
Secondary	Exercise capacity improvement measured by six minute walking test		3 months
Secondary	Exercise capacity improvement measured by maximun o2 consumption		3 months