An interventional study of Standard Clinical and Functional Assessment and Overnight Polysomnography in Precapillary Pulmonary Hypertension, Pulmonary Arterial Hypertension and Sleep-disordered Breathing, sponsored by University Hospital, Rouen. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Basic science
Background and Rationale:
Sleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. In obstructive sleep apnea, nocturnal hypoxic burden-defined as the area under the SpO₂ desaturation curve associated with respiratory events (%.min/h)-has demonstrated strong prognostic value for cardiovascular morbidity and mortality. However, its role in precapillary PH has not yet been investigated. Evaluating hypoxic burden in this population may refine indications and therapeutic targets for nocturnal oxygen therapy.
In addition, pulmonary hypertension is characterized by autonomic nervous system (ANS) dysfunction, including increased sympathetic tone, reduced heart rate variability (HRV), and a higher incidence of cardiac arrhythmias, all associated with worse prognosis. The reduction in HRV is particularly deleterious when occurring during restorative slow-wave sleep (N3), a phase marked by predominant parasympathetic activity essential for cardiovascular recovery and homeostasis. A better understanding of the interaction between nocturnal hypoxemia and ANS modulation may provide new prognostic markers and potential therapeutic targets in PH.
Objectives:
Study Design and Population:
This is a prospective, single-center observational cohort study conducted at the Pulmonary Hypertension Referral Center of Rouen University Hospital. The cohort design allows longitudinal assessment of HRV, hypoxic burden, and clinical status, enabling both cross-sectional and longitudinal correlation analyses, as well as prognostic evaluation. A total of 60 adult patients (≥18 years) with precapillary pulmonary hypertension confirmed by right heart catheterization and requiring pulmonary arterial vasodilator therapy will be included.
Participants will undergo full overnight polysomnography (PSG) at:
Descriptive analyses and cross-sectional correlations will pool repeated measures (excluding incident baseline values for generalization to prevalent cases). Intra-subject correlation will be accounted for using bootstrap methods. Longitudinal analyses will assess changes over time and prognostic associations. The prognostic value of HRV and hypoxic burden will be evaluated over a 2-year follow-up period. This study explores an original dimension of precapillary pulmonary hypertension pathophysiology by investigating the interaction between nocturnal oxygenation, autonomic dysfunction, and clinical evolution. Identification of hypoxic burden and HRV as prognostic markers may contribute to improved risk astratification and therapeutic optimization in this high-risk population.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's planned enrollment of 60 is above the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
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Inclusion Criteria:
Non-Inclusion Criteria:
Participants are hospitalized for 5 days (4 nights) at baseline, Month 12 (M12), and Month 24 (M24) in the pulmonology department for routine clinical reassessment. During each hospitalization, patients undergo standard-of-care clinical evaluation including physical examination, NYHA functional class assessment, NT-proBNP measurement, arterial blood gas analysis, 6-minute walk test, transthoracic echocardiography, and pulmonary function testing. At baseline (incident cases only), additional diagnostic procedures may include thoracic CT scan, ventilation/perfusion lung scintigraphy, and right heart catheterization. An overnight polysomnography (PSG) is performed during each hospitalization (baseline, M12, M24). Heart rate variability (HRV) parameters and nocturnal hypoxic burden are derived from PSG recordings. No experimental therapeutic intervention is assigned. All patients receive guideline-based management according to current European recommendations for pulmonary hypertension
Other: Standard Clinical and Functional Assessment · Other: Overnight Polysomnography
Routine evaluation of pulmonary hypertension during scheduled hospitalizations at baseline, Month 12, and Month 24, including: * Physical examination and NYHA functional class assessment * NT-proBNP measurement * Arterial blood gases * 6-minute walk test * Transthoracic echocardiography * Pulmonary function testing For incident cases at diagnostic evaluation only: thoracic CT scan, ventilation/perfusion lung scintigraphy, and right heart catheterization. All procedures are performed as part of standard clinical care.
Standard overnight in-hospital polysomnography performed at baseline, Month 12, and Month 24. The recording includes electrocardiogram (ECG), oxygen saturation (SpO₂), respiratory parameters, and sleep staging. Heart rate variability (HRV) is assessed using RMSSD, LF/HF ratio, and HF power derived from ECG during a continuous ≥30-minute NREM sleep period. Nocturnal hypoxic burden is calculated as the area under the SpO₂ desaturation curve associated with respiratory events divided by total sleep time (%.min/h).
Hypoxic Load
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as % min/h during polysomnographies
Time frame: Baseline, after 12 months and after 24 months
Root mean square of successive differences (RMSSD)
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Low frequency / high frequency (LF/HF)
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep, lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
High frequency (HF)
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep, lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV RMSSD
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV LF/HF
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV HF
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Hypoxic load
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as %.min/h during polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correaltion - HRV Desaturation
As a percentage of time spent with SpO2 \< 90%
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Apnea-hypopnea index
In number per hour of sleep
Time frame: Baseline, after 12 months and after 24 months
Cross-sectional correlation - HRV Pulmonary hypertension
Defined by the 4-strata risk assessment (low, intermediate low, and high risk) based on NYHA functional class, the 6-minute walk test, and NTproBNP
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV RMSSD
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV LF/HF
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV HL
Obtained by Labchart software from an electrocardiogram during a period of NREM (non-rapid eye movement) sleep lasting at least 30 minutes, the earliest after falling asleep as measured by polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Hypoxic load
Assessed by the area under the SpO2 curve during desaturations associated with respiratory events divided by sleep time expressed as %.min/h during polysomnography.
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Desaturation
As a percentage of time spent with SpO2 \< 90%
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Apnea-hypopnea index
In number per hour of sleep.
Time frame: Baseline, after 12 months and after 24 months
Correlation of evolution - HRV Pulmonary hypertension
Defined by the 4-strata risk assessment (low, intermediate low, and high risk) based on NYHA functional class, the 6-minute walk test, and NTproBNP
Time frame: Baseline, after 12 months and after 24 months
Analysis of the 2-year prognostic value of hypoxic load and HRV for an unfavorable prognosis defined by a composite event
Based on : * The occurrence of right heart failure * The introduction of additional vasodilator therapy * The introduction of non-invasive ventilation therapy * Death * Lung or heart-lung transplantation.
Time frame: After 2 years
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University Hospital, Rouen