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Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension

Study Searching for Hypoxemic Sleep Breathing Disorders in a Cohort of Patients With Idiopathic Pulmonary Arterial Hypertension (IPAH) and Chronic Post-embolic Pulmonary Hypertension (CPEPH)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01371669
Acronym
Sommeil_HTAP
Enrollment
50
Registered
2011-06-13
Start date
2010-06-30
Completion date
2011-07-31
Last updated
2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Keywords

Pulmonary arterial hypertension, Chronic post embolic disease, Sleep hypoxemia, polysomnography, sleep apnea, periodic respiration

Brief summary

In the investigators study, and regarding results of small cohorts in the literature, the investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators will explore these patients with a one night polysomnography and transcutaneous capnography, searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.

Detailed description

Pulmonary hypertension (PH) is a rare and severe disease of young adults, characterized by a progressive increase in pulmonary vascular resistances leading to cardiac failure and death. Patients with PH are categorized in two major groups: primary PH (PPH) wich is idiopathic, and secondary PH associated with many conditions such as chronic pulmonary embolic diseases (CPED).Increase in vascular resistance in PH is secondary to vasoconstriction and to a proliferative remodeling process of the arterial wall leading to obliteration of the small arterioles. On the other hand, hypoxemia is known to cause similar changes in vascular architecture. Also, some small cohorts study in the literature mentioned an increase of sleep hypoxemia prevalence accounting for almost 70% of cases. The mechanisms of this hypoxemia are completely unknown.Our study is observational, prospective and transversal, searching for hypoxemic respiratory sleep disorders (HRSD) in PPH and in CPEPH. Included patients will have one night polysomnography (CIDELEC) with a continuous measurement of transcutaneous PCO2.The major objectives are to determine the prevalence of HRSD, their physiopathologic mechanisms and their possible causal factors according to PH history, clinical findings and hemodynamic severity.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patient aged 18 to 75 years * Patient with IPAH ot CPEPH stable for at least 3 months. Stability is defined by the New York Heart Association classes for dyspnea and the six minutes walking test (6MWT). Furthermore, no changes in medical therapy had occured during the last three months. * Patients who signed informed consent

Exclusion criteria

* Patients with secondary PH associated with other pathologies outside CPEPH ( sclerodermia, systemic lupus erythematous, portal hypertension, chronic HIV infection...) * Patients who had a functional and/or a hemodynamic degradation during the last 3 months or a change in pulmonary hypertension treatment * Patients with obstructive or restrictive ventilatory disorder with a Ventricular Ejection Fraction \<60% predicted * Women without effective contraception * Patients with a Body Mass Index above 35 kg/m2 * Patient not affiliated to a social security scheme

Design outcomes

Primary

MeasureTime frameDescription
hypoxemia during the nightat the inclusionprevalence of nocturnal hypoxemia in IPAH and CPEPH

Secondary

MeasureTime frameDescription
Predictors: physical, functional and hemodynamical dataat the inclusionPredictive factors of sleep hypoxemia in IPAH and CPEPH
Physiopathologic mechanisms: causes of nocturnal hypoxemia: hypoventilation, sleep disordered breathing, shunting, V/Q mismatchat the inclusionPhysiopathologic mechanisms of sleep hypoxemia in IPAH and CPEPH

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026