Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635010
• Other study ID #: ASSIMVOP012
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2012
• Last updated: July 5, 2012
• Start date: December 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à Pesquisa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Metabolic Syndrome X
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• continuous positive airway pressure (CPAP)
CPAP pressure is individually prescript according to polysomnography for CPAP titration

Locations

Country	Name	City	State
Brazil	Associação Fundo de Incentivo à Pesquisa	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory marker (high sensitive C-reactive protein)		3 months	No
Primary	Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)		3 months	No
Primary	Arterial stiffness (pulse wave velocity)		3 months	No
Primary	Angiotensin converting enzyme activity		3 months	No