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The Induction of IL-6 by NF-kB in PBMC in OSA (OSA)

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • severe obstructive sleep apnea (AHI>=30 /hr) male older than 18 y/o

Exclusion Criteria:

  • refuse participate, chronic lung disease active infection neurologic event

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The levels of IL-6 mRNA expression and activation of NF-B in peripheral blood monocytes were higher in OSA patients than normal subjects. And increased IL-6 mRNA expression and activation of NF-B go down after 4-week CPAP treatment.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2007
    Last Updated
    July 8, 2007
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00498381
    Brief Title
    The Induction of IL-6 by NF-kB in PBMC in OSA
    Acronym
    OSA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim of study: To compare the level of IL-6 mRNA expression in peripheral blood monocytes between normal subjects and patients with OSAS To compare the activation of NF-B in peripheral blood monocytes between control subjects and patients with OSAS; Check the correlation between level of L-6 mRNA expression and activation of NF-kB To determine the effect of CPAP on the activation of NF-kB and IL-6 in peripheral blood monocytes in patients with moderate -severe OSAS
    Detailed Description
    Obstructive sleep apnea syndrome (OSAS) has emerged in recent years as an important risk factor for cardiovascular morbidity. The mechanisms responsible for developments of cardiovascular sequelae in patients with OSA include hypoxia, hypercapnia, exaggerated negative intrathoracic pressure and bursts of sympathetic activity provoking surges in blood pressure and heart rate. Meanwhile, increase of inflammatory mediators, which included C-reactive protein (CRP), oxidative stress, adhesion molecules, vascular endothelial growth factor (VEGF) and proinflammatory cytokines (interleukin (IL) -1, IL-2, IL-6, IL-8, IL-10 and tumor necrotic factor- (TNF-)), also involve in the development of cardiovascular disease in patients with OSAS. According to our preliminary study, serum levels of IL-6 and CRP were higher in patients with OSAS than control subjects and levels of both IL-6 and CRP were highly correlated with the lowest pulse oxygen saturation. Hypoxia triggered the production of IL-6 through the induction of NFB, which was demonstrated in ischemic heart disease and pancreatitis. However, this mechanism has not been prooved in OSAS. Therefore, we conduct this study to prove our hypothesis (1) The mRNA expression of IL-6 in peripheral blood monocytes was significantly higher in patients with OSAS than control subjects (2) The activation of NF-k B in peripheral blood monocytes was more significant in patients with OSAS than control subjects, and the level of NF- kB activation is associated with the level of IL-6 mRNA expression (3) CPAP therapy could lower both the activation of NF-kB and IL-6 mRNA expression in patients with moderate-severe OSAS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea, Obstructive

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    CPAP
    Primary Outcome Measure Information:
    Title
    The levels of IL-6 mRNA expression and activation of NF-B in peripheral blood monocytes were higher in OSA patients than normal subjects. And increased IL-6 mRNA expression and activation of NF-B go down after 4-week CPAP treatment.
    Time Frame
    patients evaluated before and in the end of four-week after CPAP treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: severe obstructive sleep apnea (AHI>=30 /hr) male older than 18 y/o Exclusion Criteria: refuse participate, chronic lung disease active infection neurologic event
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hey-Dong Wu, M.D.
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Induction of IL-6 by NF-kB in PBMC in OSA

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