Ireland
--:--IST
Recruiting Observational

Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension

NCT05595200 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2020-05-01
Last updated
2026-10-26

Condition(s) studied

Sleep ApneaObstructive Sleep ApneaPulmonary HypertensionEpidemiologyPredictorPrognosisOutcomesMortality

Investigational drug(s) / intervention(s)

Level III portable sleep study

Level III portable sleep study: Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge

Study summary

The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI\<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity, worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension, or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Aged ≥18 years old * Diagnosed with pulmonary hypertension by right heart catheterization Exclusion Criteria: * Pregnancy * Central sleep apnea * Previous treatment for sleep-disordered breathing * Unavailable or incomplete sleep data * Requiring nocturnal oxygen supplementation

Primary outcome measure(s)

  • Clinical worsening — 1 year
    The composite event of a reduction in exercise capacity (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality.

Trial sites (1)

FacilityCityRegionStatus
Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05595200 on ClinicalTrials.gov ↗ ← All trials in China