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Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

A

Associação Fundo de Incentivo à Pesquisa

Status and phase

Completed
Phase 4

Conditions

Obstructive Sleep Apnea

Treatments

Procedure: continuous positive airway pressure (CPAP)

Study type

Interventional

Funder types

Other

Identifiers

NCT01635010
ASSIMVOP012

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

Male

Ages

25 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Control
No Intervention group
Obstructive sleep apnea
Experimental group
Treatment:
Procedure: continuous positive airway pressure (CPAP)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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