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CompletedNCT01371669Sommeil_HTAPUpdated Mar 29, 2013

Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension

An observational study in Sleep Disorders, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-03-29.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep Disorders

Keywords

  • Pulmonary arterial hypertension
  • Chronic post embolic disease
  • Sleep hypoxemia
  • polysomnography
  • sleep apnea
  • periodic respiration
03

In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 197 observational studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)

Groups and cohorts

  • IPAH or CPEPH

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

06

What researchers measure

Primary outcomes

  1. hypoxemia during the night

    prevalence of nocturnal hypoxemia in IPAH and CPEPH

    Time frame: at the inclusion

Secondary outcomes

  1. Predictors: physical, functional and hemodynamical data

    Predictive factors of sleep hypoxemia in IPAH and CPEPH

    Time frame: at the inclusion

  2. Physiopathologic mechanisms: causes of nocturnal hypoxemia: hypoventilation, sleep disordered breathing, shunting, V/Q mismatch

    Physiopathologic mechanisms of sleep hypoxemia in IPAH and CPEPH

    Time frame: at the inclusion

07

Study locations

1 site
  • Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital
    Clamart, 92141, France
08

References and documents

Publications

  • Jilwan FN, Escourrou P, Garcia G, Jais X, Humbert M, Roisman G. High occurrence of hypoxemic sleep respiratory disorders in precapillary pulmonary hypertension and mechanisms. Chest. 2013 Jan;143(1):47-55. doi: 10.1378/chest.11-3124. PubMed 22878784 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01371669
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 13, 2011
Start date
Jun 2010
Primary completion
Jul 2011
Completion
Jul 2011
Last update
Mar 29, 2013

Study contacts

Gabriel ROISMAN, MD
principal investigator · Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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