CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

NCT04769635 | Completed

• 1 other identifier: ZU-IRB#5654
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change of mean pulmonary artery pressure measured by echo

  3 months

Secondary Outcomes (2)

• Exercise capacity improvement measured by six minute walking test

  3 months

• Exercise capacity improvement measured by maximun o2 consumption

  3 months

Study Arms (1)

CPAP ttt

EXPERIMENTAL

Device: CPAP therapy

Interventions

CPAP therapy 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

CPAP ttt

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Ahmad Abbas

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of chest diseases

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 24, 2021
• Study Start: October 15, 2019
• Primary Completion: April 20, 2020
• Study Completion: October 15, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

EG (1)