Right Ventricular Function in Patients With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01201200
First received: September 13, 2010
Last updated: May 7, 2012
Last verified: June 2010

September 13, 2010
May 7, 2012
June 2007
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Complete list of historical versions of study NCT01201200 on ClinicalTrials.gov Archive Site
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Right Ventricular Function in Patients With Obstructive Sleep Apnea
Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Obstructive Sleep Apnea
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
November 2007
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Inclusion Criteria:

  • Individuals > 18 years old and < 70.

Exclusion Criteria:

  • Body mass index greater than 35
  • Past of clinically significant cardiac conditions
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01201200
Eco2
Yes
Wercules Oliveira, AFIP/Escola Paulista de Medicina
Associação Fundo de Incentivo à Pesquisa
Not Provided
Study Director: Orlando Campos, PhD Escola Paulista de Medicina
Associação Fundo de Incentivo à Pesquisa
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP