Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 6, 2012
CompletedJuly 6, 2012
July 1, 2012
3 years
June 29, 2012
July 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Control
NO INTERVENTIONObstructive sleep apnea
EXPERIMENTALInterventions
CPAP pressure is individually prescript according to polysomnography for CPAP titration
Eligibility Criteria
You may qualify if:
- male subjects
- apnea-hypopnea index \> 15/h (OSA group)
- apnea-hypopnea index \< 5/h (control group)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04020-060, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctoral researcher
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 6, 2012
Study Start
December 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 6, 2012
Record last verified: 2012-07