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The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00498849
Recruitment Status : Unknown
Verified January 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 10, 2007
Last Update Posted : July 10, 2007
Information provided by:

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

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Device: CPAP

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
Study Start Date : February 2005
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. CPAP effect [ Time Frame: 4-week after CPAP treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498849

Contact: Peilin Leee, M.D. +886-2-23562905 peilin1986@yahoo.com.tw

Naitonal Taiwan Univerisity Hospital Recruiting
Taipei, Taiwan, 100
Contact: Peilin Lee, M.D.    +886-23562905    peilin1986@yahoo.com.tw   
Principal Investigator: Peilin Lee, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Peilin Lee, M.D. National Taiwan University Hospital
More Information

ClinicalTrials.gov Identifier: NCT00498849     History of Changes
Other Study ID Numbers: 9361701236
NSC 94-2314-B-002-218-
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: January 2005

Keywords provided by National Taiwan University Hospital:
Sleep apnea
Continuous positive airway pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases