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

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: continuous positive airway pressure (CPAP)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04020-060
    • Associação Fundo de Incentivo à Pesquisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Obstructive sleep apnea	Procedure: continuous positive airway pressure (CPAP); CPAP pressure is individually prescript according to polysomnography for CPAP titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Angiotensin converting enzyme activity	3 months

Collaborators and Investigators

• Sponsor: Associação Fundo de Incentivo à Pesquisa
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Daniela K. Andaku, MSc, Associação Fundo de Incentivo à Pesquisa; Study Chair: Sônia M. Togeiro, PhD, Associação Fundo de Incentivo à Pesquisa; Study Chair: Vânia D'Almeida, PhD, Associação Fundo de Incentivo à Pesquisa

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 5, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; inflammation; oxidative stress; arterial stiffness
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Insulin Resistance; Hyperinsulinism; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Metabolic Syndrome
• Other Study ID Numbers: ASSIMVOP012