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CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04769635
Enrollment
50
Registered
2021-02-24
Start date
2019-10-15
Completion date
2020-10-15
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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).

Interventions

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

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
change of mean pulmonary artery pressure measured by echo3 months

Secondary

MeasureTime frame
Exercise capacity improvement measured by six minute walking test3 months
Exercise capacity improvement measured by maximun o2 consumption3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026