Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wercules Antonio Alves de Oliveira, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT00768807
First received: October 6, 2008
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.


Condition Intervention
Obstructive Sleep Apnea
Device: CPAP (continuous positive airway pressure)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Improvement of left ventricular diastolic echo variable [ Time Frame: 06 months ] [ Designated as safety issue: Yes ]

Enrollment: 450
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham CPAP
Patients submitted to SHAM CPAP use for 06 months
Device: CPAP (continuous positive airway pressure)
Patients treated by CPAP for 06 months
Active Comparator: CPAP
OSA patients submitted to 06 months of CPAP treatment
Device: CPAP (continuous positive airway pressure)
Patients treated by CPAP for 06 months

Detailed Description:

Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria:

  • Body mass index higher than 40 kg/m2
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768807

Locations
Brazil
Instituto do Sono/AFIP
Sao Paulo, Brazil, 04516001
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
  More Information

No publications provided by Associação Fundo de Incentivo à Pesquisa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wercules Antonio Alves de Oliveira, Dr., Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT00768807     History of Changes
Other Study ID Numbers: ECOera-03
Study First Received: October 6, 2008
Last Updated: May 4, 2012
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on July 20, 2014