Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
continuous positive airway pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, inflammation, oxidative stress, arterial stiffness
Eligibility Criteria
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
Sites / Locations
- Associação Fundo de Incentivo à Pesquisa
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Obstructive sleep apnea
Arm Description
Outcomes
Primary Outcome Measures
Inflammatory marker (high sensitive C-reactive protein)
Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)
Arterial stiffness (pulse wave velocity)
Angiotensin converting enzyme activity
Secondary Outcome Measures
Full Information
NCT ID
NCT01635010
First Posted
June 29, 2012
Last Updated
July 5, 2012
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
1. Study Identification
Unique Protocol Identification Number
NCT01635010
Brief Title
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
Official Title
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, inflammation, oxidative stress, arterial stiffness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Obstructive sleep apnea
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
continuous positive airway pressure (CPAP)
Intervention Description
CPAP pressure is individually prescript according to polysomnography for CPAP titration
Primary Outcome Measure Information:
Title
Inflammatory marker (high sensitive C-reactive protein)
Time Frame
3 months
Title
Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)
Time Frame
3 months
Title
Arterial stiffness (pulse wave velocity)
Time Frame
3 months
Title
Angiotensin converting enzyme activity
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela K. Andaku, MSc
Organizational Affiliation
Associação Fundo de Incentivo à Pesquisa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sônia M. Togeiro, PhD
Organizational Affiliation
Associação Fundo de Incentivo à Pesquisa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vânia D'Almeida, PhD
Organizational Affiliation
Associação Fundo de Incentivo à Pesquisa
Official's Role
Study Chair
Facility Information:
Facility Name
Associação Fundo de Incentivo à Pesquisa
City
São Paulo
ZIP/Postal Code
04020-060
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome
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