We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea

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.
ClinicalTrials.gov Identifier: NCT00570115
Recruitment Status : Completed
First Posted : December 10, 2007
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 left atrial morphology and function evaluated by echocardiography three dimensional

Condition or disease
Sleep Apnea Syndromes

Detailed Description:
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.

Study Design

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Left Atrial Volume and 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
A
The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea


Outcome Measures

Primary Outcome Measures :
  1. Left Atrial enlargement [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) >5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.
Criteria

Inclusion Criteria:

  • Age from 30 to 70
  • Apnea-hypopnea index > 5 by polysomnography

Exclusion Criteria:

  • Any cardiac disease
  • Poor imaging quality by mean of echocardiography
  • non-sinusal Rhythm
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): NCT00570115


Locations
Brazil
Instituto do Sono/Federal University of Sao Paulo
Sao Paulo, Brazil, 04020060
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Investigators
Study Director: Sergio Tufik, PhD,MD. Federal University of Sao Paulo
More Information

Publications:
Responsible Party: Wercules Antonio Alves de Oliveira, AFIP/Instituto do Sono
ClinicalTrials.gov Identifier: NCT00570115     History of Changes
Other Study ID Numbers: ecoera-001
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: December 2007

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
Sleep Apnea Syndromes diastolic disfunction left atrium

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