The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Sleep apnea, Continuous positive airway pressure, Microarray, Polysomnography
Eligibility Criteria
Inclusion Criteria:
- healthy control with age > 18 y/o severe OSA (AHI>=30/hr) with age>18 y/o
Exclusion Criteria:
- chronic lung disease female refuse to receive CPAP treatment or poor compliant to CPAP neurologic event
Sites / Locations
- Naitonal Taiwan Univerisity HospitalRecruiting
Outcomes
Primary Outcome Measures
CPAP effect
Secondary Outcome Measures
Full Information
NCT ID
NCT00498849
First Posted
July 8, 2007
Last Updated
July 8, 2007
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00498849
Brief Title
The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
Official Title
The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study are (1) To genome-wide profile the gene expression patterns of peripheral blood mononuclear cell (PBMC) in patients with obstructive sleep apnea (OSA) (2) To profile the gene expression patterns change before and after treatment with continuous positive airway pressure (CPAP) (3) To correlate the altered gene expression with the severity of the disease and outcome of OSA patients
Detailed Description
Obstructive sleep apnea syndrome (OSAS) is characterized with recurrent collapse of upper airway during sleep and resulted in hypoxia and sleep fragmentation. Several systemic and cardiovascular complications have been attributed to OSAS, which is caused by hypoxia and bursts of sympathetic activity. Increase of inflammatory mediators, which included C-reactive protein, oxidative stress, adhesion molecules, vascular endothelial growth factor and proinflammatory cytokines, were thought to involve in the developments of cardiovascular diseases in patients with OSAS. In our preliminary study, both serum levels of IL-6 and CRP were higher in patients with OSAS than control subjects, and the levels were inversely correlated with the lowest pulse oxygen saturation. Factors triggering inflammatory cascades in OSAS included hypoxia and sympathetic hyperactivity.
Hypoxia was thought to be the trigger factor for the elevated production of inflammatory mediators. Through the induction of transcriptional factors and critical signaling pathways, hypoxia induces several physiologic responses, like increased anaerobic metabolism, angiogenesis, vasodilation, erythropoiesis and increased breathing.
Microarray is the more mature gene analysis techniques so far, which can allow high throughput analysis of the function of many genes. Microarray can be used to understand the disease mechanisms and is also very useful to improve disease diagnosis, disease classification, prognosis evaluation and to improve treatment outcome. In this project, we use oligo microarray to genome-wide profile the altered gene expressions in peripheral blood mononuclear cells of OSAS patients; and to correlate the dysregulations of gene expression with the clinical outcome. We will also examine the gene expression patterns change before and after treatment with CPAP. The information obtained by this approach will be very useful to understand the pathogenic mechanism of OSAS that leads to the systemic and cardiovascular complications. Further therapeutic intervention may therefore be possible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Sleep apnea, Continuous positive airway pressure, Microarray, Polysomnography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CPAP
Primary Outcome Measure Information:
Title
CPAP effect
Time Frame
4-week after CPAP treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy control with age > 18 y/o severe OSA (AHI>=30/hr) with age>18 y/o
Exclusion Criteria:
chronic lung disease female refuse to receive CPAP treatment or poor compliant to CPAP neurologic event
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peilin Leee, M.D.
Phone
+886-2-23562905
Email
peilin1986@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peilin Lee, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naitonal Taiwan Univerisity Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peilin Lee, M.D.
Phone
+886-23562905
Email
peilin1986@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Peilin Lee, M.D.
12. IPD Sharing Statement
Learn more about this trial
The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
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