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Right Ventricular Function in Patients With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201200
First Posted: September 14, 2010
Last Update Posted: May 8, 2012
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.
Information provided by:
Associação Fundo de Incentivo à Pesquisa
  Purpose
The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.

Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography

Resource links provided by NLM:


Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Enrollment: 106
Study Start Date: June 2007
Study Completion Date: November 2007
Groups/Cohorts
Group 1 - Obstructive Sleep Apnea (OSA)
Fifty-six patients with Obstructive Sleep Apnea
Group 2 - Non-OSA Controls
Fifty individuals without OSA with similar age, gender and body mass index (BMI)
Group 3 - Treatment
Fifteen patients with moderate and severe sleep apnea from group 1 underwent treatment with continuous positive airway pressure
Group 4 - Placebo
Fifteen patients with moderate/severe sleep apnea underwent to placebo

Detailed Description:
Several studies have reported the association between sleep disorders to an increased risk to the development of cardiac disease. However, there is no substantial that about the influence of Obstructive Sleep Apnea on the right ventricular function. Objective: to analyse the right ventricular function in patients with Obstructive Sleep Apnea by means of Real-Time Three dimensional Echocardiography.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Initially, 56 patients with obstructive sleep apnea (OSA) and 50 non-OSA controls underwent real-time three-dimensional echocardiography. 30 Patients with moderate and severe OSA underwent to continuous positive airway pressure treatment over 6 months. Echocardiogram will be repeated on the third and sixth months from the treatment onset.
Criteria

Inclusion Criteria:

  • Individuals > 18 years old and < 70.

Exclusion Criteria:

  • Body mass index greater than 35
  • Past of clinically significant cardiac conditions
  Contacts and Locations
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): NCT01201200


Locations
Brazil
Escola Paulista de Medicina
Sao Paulo, Brazil, 04516001
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Investigators
Study Director: Orlando Campos, PhD Escola Paulista de Medicina
  More Information

Responsible Party: Wercules Oliveira, AFIP/Escola Paulista de Medicina
ClinicalTrials.gov Identifier: NCT01201200     History of Changes
Other Study ID Numbers: Eco2
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: May 8, 2012
Last Verified: June 2010

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
Obstructive Sleep Apnea
Right Ventricular Function
Pulmonary Hypertension

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases