CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

NCT ID: NCT04769635

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-10-15

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).

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP ttt

Group Type: EXPERIMENTAL

CPAP therapy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmad Abbas

Lecturer of chest diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmad Abbas

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB#5654

Identifier Type: -

Identifier Source: org_study_id