Right Ventricular Function in Patients With Obstructive Sleep Apnea

NCT ID: NCT01201200

Last Updated: 2012-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 - Obstructive Sleep Apnea (OSA)

Fifty-six patients with Obstructive Sleep Apnea

No interventions assigned to this group

Group 2 - Non-OSA Controls

Fifty individuals without OSA with similar age, gender and body mass index (BMI)

No interventions assigned to this group

Group 3 - Treatment

Fifteen patients with moderate and severe sleep apnea from group 1 underwent treatment with continuous positive airway pressure

No interventions assigned to this group

Group 4 - Placebo

Fifteen patients with moderate/severe sleep apnea underwent to placebo

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Individuals \> 18 years old and \< 70.

Exclusion Criteria

* Body mass index greater than 35
* Past of clinically significant cardiac conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role lead

Responsible Party

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AFIP/Escola Paulista de Medicina

Principal Investigators

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Orlando Campos, PhD

Role: STUDY_DIRECTOR

Escola Paulista de Medicina

Locations

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Escola Paulista de Medicina

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Eco2

Identifier Type: -

Identifier Source: org_study_id

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