Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP (continuous positive airway pressure)
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Apnea-hypopnea index higher than 5 events per hour
Exclusion Criteria:
- Body mass index higher than 40 kg/m2
Sites / Locations
- Instituto do Sono/AFIP
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham CPAP
CPAP
Arm Description
Patients submitted to SHAM CPAP use for 06 months
OSA patients submitted to 06 months of CPAP treatment
Outcomes
Primary Outcome Measures
Improvement of left ventricular diastolic echo variable
Secondary Outcome Measures
Full Information
NCT ID
NCT00768807
First Posted
October 6, 2008
Last Updated
May 4, 2012
Sponsor
Associação Fundo de Incentivo à Pesquisa
1. Study Identification
Unique Protocol Identification Number
NCT00768807
Brief Title
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
Official Title
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associação Fundo de Incentivo à Pesquisa
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham CPAP
Arm Type
Sham Comparator
Arm Description
Patients submitted to SHAM CPAP use for 06 months
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
OSA patients submitted to 06 months of CPAP treatment
Intervention Type
Device
Intervention Name(s)
CPAP (continuous positive airway pressure)
Intervention Description
Patients treated by CPAP for 06 months
Primary Outcome Measure Information:
Title
Improvement of left ventricular diastolic echo variable
Time Frame
06 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Apnea-hypopnea index higher than 5 events per hour
Exclusion Criteria:
Body mass index higher than 40 kg/m2
Facility Information:
Facility Name
Instituto do Sono/AFIP
City
Sao Paulo
ZIP/Postal Code
04516001
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19643769
Citation
Oliveira W, Campos O, Cintra F, Matos L, Vieira ML, Rollim B, Fujita L, Tufik S, Poyares D. Impact of continuous positive airway pressure treatment on left atrial volume and function in patients with obstructive sleep apnoea assessed by real-time three-dimensional echocardiography. Heart. 2009 Nov;95(22):1872-8. doi: 10.1136/hrt.2009.173625. Epub 2009 Jul 29.
Results Reference
derived
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Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
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