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Right Ventricular Function in Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01201200
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Obstructive Sleep Apnea

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.

Study Design

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography
Study Start Date : June 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Eligibility Criteria

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 Posted: September 14, 2010    Key Record Dates
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:
Sleep Disorders, Intrinsic
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases