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

This study has been completed.
Sponsor:
Information provided by:
Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT00570115
First received: December 7, 2007
Last updated: May 7, 2012
Last verified: December 2007
History of Changes
  Purpose

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
Sleep Apnea Syndromes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Left Atrial enlargement [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: June 2007
Study Completion Date: November 2007
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 7, 2007
Last Updated: May 7, 2012
Health Authority: Brazil: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 16, 2013