Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

Phase 4

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: continuous positive airway pressure (CPAP)

• Registration Number: NCT01635010
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-06-29
• Status Verified: 2012-07
• Study First Submitted QC: 2012-07-05
• Last Update Submitted: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Posted: 2012-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obstructive sleep apnea	continuous positive airway pressure (CPAP)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Associação Fundo de Incentivo à Pesquisa; 🇧🇷 São Paulo, Brazil