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Clinical Trials/NCT01635010
NCT01635010CompletedPhase 4

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

Associação Fundo de Incentivo à Pesquisa2 sites in 1 country34 target enrollmentStarted: December 1, 2008Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
34
Locations
2
Primary Endpoint
Inflammatory marker (high sensitive C-reactive protein)

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

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

Daniela Kuguimoto Andaku Olenscki

Doctoral researcher

Associação Fundo de Incentivo à Pesquisa

Study Sites (2)

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