Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PAH-SDB is a multicenter prospective registry in China enrolling adults with confirmed WHO Group 1 PAH. Participants undergo standardized overnight sleep monitoring along with comprehensive PAH assessments, including functional status, biomarkers, imaging, hemodynamics, therapies, and outcomes. The registry aims to characterize the prevalence and patterns of sleep-disordered breathing, nocturnal hypoxemia, and their association with PAH progression and prognosis in the modern treatment era. Data will come from wearable and sleep study devices when available, enabling a broad view beyond apnea-hypopnea index. This observational design will support longitudinal analyses to identify potential targets for personalized management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years at enrollment.
* Diagnosis of WHO Group 1 pulmonary arterial hypertension established by right heart catheterization using contemporary hemodynamic criteria: mean pulmonary artery pressure \>20 mmHg at rest, pulmonary arterial wedge pressure ≤15 mmHg, and pulmonary vascular resistance \>2 Wood units, with clinical classification consistent with Group 1 PAH.
* PAH etiology may include idiopathic, heritable, drug/toxin-associated, connective-tissue-disease-associated, congenital-heart-disease-associated PAH after appropriate clinical classification, portal-hypertension-associated PAH, HIV-associated PAH, or other recognized Group 1 PAH subtypes.
* Clinically stable enough to undergo overnight sleep/cardiorespiratory monitoring, as judged by the treating team.
* Able and willing to provide written informed consent and participate in longitudinal follow-up.
* Enrollment at a participating center with availability of the required baseline PAH dataset and a technically interpretable protocol-standardized sleep recording.

Exclusion Criteria:

* Pulmonary hypertension predominantly attributable to left heart disease (Group 2), lung disease and/or hypoxia (Group 3), chronic thromboembolic pulmonary hypertension or other pulmonary artery obstruction (Group 4), or unclear/multifactorial mechanisms (Group 5).
* Pulmonary veno-occlusive disease / pulmonary capillary hemangiomatosis when the clinical phenotype is considered separately from conventional PAH for the planned analysis, unless the protocol intentionally includes this subgroup and prespecifies it as a distinct stratum.
* Acute decompensated right heart failure, cardiogenic shock, severe active infection, or another acute condition that would make the baseline sleep recording unrepresentative or unsafe; these patients may be reconsidered after stabilization.
* Current hospitalization primarily for an acute non-PAH illness likely to substantially distort nocturnal respiratory physiology.
* Inability to obtain an adequate baseline sleep/cardiorespiratory recording after protocol-defined repeat attempt, unless the participant is retained in a registry-only stratum for non-sleep analyses.
* Inability to provide informed consent or anticipated inability to complete meaningful follow-up.
* Any other condition that, in the investigator's judgment, would prevent reliable study participation or data interpretation.

Where it's running

• Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhihong Liu, MD, PhD
• Email: zhihongliufuwai@163.com
• Phone: 86-010-88398196

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.