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Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

NCT01635010 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-07-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

continuous positive airway pressure (CPAP)

CPAP pressure is individually prescript according to polysomnography for CPAP titration

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Associação Fundo de Incentivo à Pesquisa

    lead OTHER

Principal Investigators

  • Daniela K. Andaku, MSc · Associação Fundo de Incentivo à Pesquisa

  • Sônia M. Togeiro, PhD · Associação Fundo de Incentivo à Pesquisa

  • Vânia D'Almeida, PhD · Associação Fundo de Incentivo à Pesquisa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635010 on ClinicalTrials.gov