NCT07184060

Brief Summary

This study investigates the association between obstructive sleep apnea (OSA) and pulmonary hypertension (PH), focusing on the relationship between OSA severity and pulmonary arterial pressures in adult patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Oct 2025Aug 2027

First Submitted

Initial submission to the registry

September 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

September 13, 2025

Last Update Submit

September 13, 2025

Conditions

Keywords

obstructive sleep apneapulmonary hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Pulmonary Artery Pressure

    The primary objective is to assess the presence and degree of pulmonary hypertension (measured by echocardiography) in OSA patients.

    baseline

Study Arms (1)

adult patients with confirmed OSA

Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient.

You may qualify if:

  • Adults aged 18-65 years
  • Diagnosed with obstructive sleep apnea (OSA) by full-night polysomnography
  • Apnea-Hypopnea Index (AHI) ≥ 5 events/hour

You may not qualify if:

  • Secondary pulmonary hypertension due to:Chronic pulmonary diseases, Left ventricular heart disease and Chronic thromboembolic disorders
  • Use of pulmonary vasodilator therapy
  • Long-term oxygen therapy (LTOT)
  • Respiratory neuromuscular weakness
  • Chest wall deformities
  • End-organ failure (cardiac, renal, hepatic)
  • Malignancy
  • Obesity hypoventilation syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension, Pulmonary

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesLung DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at the of Chest Diseases department

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 19, 2025

Study Start

October 30, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share