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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00498849
First received: July 8, 2007
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose

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 Intervention
Sleep Apnea, Obstructive
Device: CPAP

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

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

Estimated Enrollment: 20
Study Start Date: February 2005
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00498849

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

Locations
Taiwan
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
Investigators
Principal Investigator: Peilin Lee, M.D. National Taiwan University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00498849     History of Changes
Other Study ID Numbers: 9361701236, NSC 94-2314-B-002-218-
Study First Received: July 8, 2007
Last Updated: July 8, 2007
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 02, 2014