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Clinical Trials/NCT01635010
NCT01635010
Completed
Phase 4

Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers

Associação Fundo de Incentivo à Pesquisa1 site in 1 country34 target enrollmentDecember 2008

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Associação Fundo de Incentivo à Pesquisa
Enrollment
34
Locations
1
Primary Endpoint
Inflammatory marker (high sensitive C-reactive protein)
Status
Completed
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Associação Fundo de Incentivo à Pesquisa
Responsible Party
Principal Investigator
Principal Investigator

Daniela Kuguimoto Andaku Olenscki

Doctoral researcher

Associação Fundo de Incentivo à Pesquisa

Eligibility Criteria

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

Outcomes

Primary Outcomes

Inflammatory marker (high sensitive C-reactive protein)

Time Frame: 3 months

Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)

Time Frame: 3 months

Arterial stiffness (pulse wave velocity)

Time Frame: 3 months

Angiotensin converting enzyme activity

Time Frame: 3 months

Study Sites (1)

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