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Completed

NCT Number: NCT01635010

Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Associação Fundo de Incentivo à Pesquisa

São Paulo, 04020-060, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Procedure

CPAP pressure is individually prescript according to polysomnography for CPAP titration

Primary outcomes

  1. Inflammatory marker (high sensitive C-reactive protein)

    Time frame: 3 months

  2. Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)

    Time frame: 3 months

  3. Arterial stiffness (pulse wave velocity)

    Time frame: 3 months

  4. Angiotensin converting enzyme activity

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Associação Fundo de Incentivo à Pesquisa

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 6, 2012
Registry last updated
Jul 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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