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Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

NCT ID: NCT01635010

Last Updated: 2012-07-06

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

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-12-31

Brief Summary

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Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important.

The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Keywords

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obstructive sleep apnea inflammation oxidative stress arterial stiffness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Obstructive sleep apnea

Group Type EXPERIMENTAL

continuous positive airway pressure (CPAP)

Intervention Type PROCEDURE

CPAP pressure is individually prescript according to polysomnography for CPAP titration

Interventions

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continuous positive airway pressure (CPAP)

CPAP pressure is individually prescript according to polysomnography for CPAP titration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* male subjects
* apnea-hypopnea index \> 15/h (OSA group)
* apnea-hypopnea index \< 5/h (control group)

Exclusion Criteria

* body mass index (BMI) \> 30 kg/m2
* age \> 60 years
* chronic obstructive pulmonary disease
* cardiac diseases
* diabetes mellitus
* metabolic syndrome according to modified National Cholesterol Education Program Adult Treatment Panel III criteria
* previous OSA treatment
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role lead

Responsible Party

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Daniela Kuguimoto Andaku Olenscki

Doctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela K. Andaku, MSc

Role: PRINCIPAL_INVESTIGATOR

Associação Fundo de Incentivo à Pesquisa

Sônia M. Togeiro, PhD

Role: STUDY_CHAIR

Associação Fundo de Incentivo à Pesquisa

Vânia D'Almeida, PhD

Role: STUDY_CHAIR

Associação Fundo de Incentivo à Pesquisa

Locations

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Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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ASSIMVOP012

Identifier Type: -

Identifier Source: org_study_id