Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01635010

Enrollment

Registered

2012-07-06

Start date

2008-12-31

Completion date

2011-12-31

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, inflammation, oxidative stress, arterial stiffness

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.

Interventions

PROCEDUREcontinuous positive airway pressure (CPAP)

CPAP pressure is individually prescript according to polysomnography for CPAP titration

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

25 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)	3 months
Arterial stiffness (pulse wave velocity)	3 months
Inflammatory marker (high sensitive C-reactive protein)	3 months
Angiotensin converting enzyme activity	3 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026