PAH-SDB: Sleep-Disordered Breathing and Outcomes in Pulmonary Arterial Hypertension

Condition(s) studied

Investigational drug(s) / intervention(s)

Standardized Overnight Sleep and Cardiorespiratory Monitoring: Participants undergo protocol-standardized nocturnal monitoring without study-assigned therapy. The core recording includes airflow, respiratory effort, oxygen saturation, pulse/heart rate, body position, and snoring when available. Full polysomnography, extended wearable monitoring, repeated sleep studies, and other physiological signals may be obtained in nested subcohorts. All sleep-related treatment decisions remain under routine clinical care.

Study summary

Pulmonary arterial hypertension (PAH) is a progressive pulmonary vascular disease characterized by increased pulmonary vascular resistance, right ventricular dysfunction, and clinically important morbidity and mortality. Sleep-disordered breathing (SDB) and sleep-related hypoxemia are common in patients with PAH, but their prevalence, physiological determinants, longitudinal trajectories, prognostic significance, and potential role in individualized management remain incompletely defined.

PAH-SDB is a prospective, multicenter, observational patient registry enrolling adults with right-heart-catheterization-confirmed World Health Organization Group 1 PAH at pulmonary vascular centers across China. Participants will undergo standardized nocturnal sleep and cardiorespiratory monitoring together with comprehensive PAH assessment, including clinical characteristics, functional status, biomarkers, echocardiography, hemodynamics, treatment, and outcomes. Selected participants may undergo additional polysomnography, cardiac magnetic resonance imaging, wearable monitoring, repeated sleep assessments, or biospecimen collection when available and ethically approved.

The registry will characterize the prevalence and phenotypes of sleep-disordered breathing and nocturnal physiological abnormalities; examine their relationships with PAH severity and right ventricular-pulmonary vascular function; determine their value for predicting clinical worsening, hospitalization, transplantation, and mortality; evaluate longitudinal changes in sleep physiology in relation to PAH treatment and disease trajectory; and develop and validate multimodal statistical and artificial-intelligence models for phenotyping, risk prediction, and treatment-response stratification. Clinical management will remain at the discretion of treating physicians, and the registry will not assign PAH or sleep-related therapies.

Eligibility

Primary outcome measure(s)

• Prevalence and phenotypic distribution of sleep-disordered breathing and nocturnal hypoxemia — Baseline
  Proportion of participants with sleep-disordered breathing (SDB) and its phenotypes, including obstructive sleep apnea (OSA) and central sleep apnea (CSA), together with the distribution of nocturnal hypoxemia and multidimensional sleep physiological burden. Core measures will include the apnea-hypopnea index (AHI) or respiratory event index (REI), obstructive and central respiratory event indices, oxygen desaturation index (ODI), percentage of recording time with peripheral oxygen saturation below 90% (T90), mean and minimum peripheral oxygen saturation (SpO₂), and prespecified hypoxic-burden metrics. Prevalence estimates will be reported with 95% confidence intervals.
• Time to first clinical worsening event — From enrollment through 5 years of follow-up
  Time from enrollment to the first adjudicated clinical worsening event. The primary composite is recommended to include all-cause death, lung or heart-lung transplantation, PAH-related unplanned hospitalization, atrial septostomy, or clinically driven major PAH treatment escalation/rescue therapy because of documented disease worsening. A sensitivity definition limited to hard outcomes will also be analyzed.

Trial sites (1)

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