We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension (Sommeil_HTAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01371669
Recruitment Status : Completed
First Posted : June 13, 2011
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease
Sleep Disorders

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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : June 2010
Primary Completion Date : July 2011
Study Completion Date : July 2011

Idiopathic pulmonary arterial hypertension (IPAH) or pulmonary hypertension associated with chronic post-embolic pulmonary hypertension (CPEPH)

Primary Outcome Measures :
  1. hypoxemia during the night [ Time Frame: at the inclusion ]
    prevalence of nocturnal hypoxemia in IPAH and CPEPH

Secondary Outcome Measures :
  1. Predictors: physical, functional and hemodynamical data [ Time Frame: at the inclusion ]
    Predictive factors of sleep hypoxemia in IPAH and CPEPH

  2. Physiopathologic mechanisms: causes of nocturnal hypoxemia: hypoventilation, sleep disordered breathing, shunting, V/Q mismatch [ Time Frame: at the inclusion ]
    Physiopathologic mechanisms of sleep hypoxemia in IPAH and CPEPH

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with IPAH or CPEPH hospitalized in our pulmonary department for a standard follow-up. They have to be in a stable condition, as defined by the New York Heart Association classes for dyspnea and the six minutes walking test. Furthermore, no changes in medical therapy could have been made during the last three months.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371669

Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Gabriel ROISMAN, MD Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01371669     History of Changes
Other Study ID Numbers: P090206
First Posted: June 13, 2011    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary arterial hypertension
Chronic post embolic disease
Sleep hypoxemia
sleep apnea
periodic respiration

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Sleep Wake Disorders
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders