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CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CPAP therapy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmad Abbas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP ttt

Arm Description

Outcomes

Primary Outcome Measures

change of mean pulmonary artery pressure measured by echo

Secondary Outcome Measures

Exercise capacity improvement measured by six minute walking test
Exercise capacity improvement measured by maximun o2 consumption

Full Information

First Posted
February 20, 2021
Last Updated
February 23, 2021
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04769635
Brief Title
CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension
Official Title
Impact of Continuous Positive Airway Pressure Therapy on Pulmonary Hypertension and Exercise Capacity in Newly Diagnosed Obstructive Sleep Apnea Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP ttt
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CPAP therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
change of mean pulmonary artery pressure measured by echo
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Exercise capacity improvement measured by six minute walking test
Time Frame
3 months
Title
Exercise capacity improvement measured by maximun o2 consumption
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ahmad Abbas
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

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CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

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