Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension

NCT01371669 | Completed

• 1 other identifier: P090206
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• hypoxemia during the night

  prevalence of nocturnal hypoxemia in IPAH and CPEPH

  at the inclusion

Secondary Outcomes (2)

• Predictors: physical, functional and hemodynamical data

  at the inclusion

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

  at the inclusion

Study Arms (1)

IPAH or CPEPH

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital

Clamart, 92141, France

Location

Related Publications (1)

• 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.

  PMID: 22878784 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Pulmonary Arterial Hypertension; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Gabriel ROISMAN, MD

  Assistance Publique - Hopitaux de Paris, Hôpital Antoine Beclere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: June 13, 2011
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

FR (1)