- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201200
Right Ventricular Function in Patients With Obstructive Sleep Apnea
May 7, 2012 updated by: Associação Fundo de Incentivo à Pesquisa
Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
106
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sao Paulo, Brazil, 04516001
- Escola Paulista de Medicina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Individuals > 18 years old and < 70.
Exclusion Criteria:
- Body mass index greater than 35
- Past of clinically significant cardiac conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1 - Obstructive Sleep Apnea (OSA)
Fifty-six patients with Obstructive Sleep Apnea
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Group 2 - Non-OSA Controls
Fifty individuals without OSA with similar age, gender and body mass index (BMI)
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Group 3 - Treatment
Fifteen patients with moderate and severe sleep apnea from group 1 underwent treatment with continuous positive airway pressure
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Group 4 - Placebo
Fifteen patients with moderate/severe sleep apnea underwent to placebo
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Orlando Campos, PhD, Escola Paulista de Medicina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 13, 2010
First Submitted That Met QC Criteria
September 13, 2010
First Posted (Estimate)
September 14, 2010
Study Record Updates
Last Update Posted (Estimate)
May 8, 2012
Last Update Submitted That Met QC Criteria
May 7, 2012
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eco2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
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LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
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Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
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University of California, Los AngelesRecruiting
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Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
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State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
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The Hospital for Sick ChildrenCompleted
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Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
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State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
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Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
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ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States