Sleep Apnea, ObstructiveNCT00498849
The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
A study testing CPAP in people with Sleep Apnea, Obstructive, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy control with age > 18 y/o severe OSA (AHI>=30/hr) with age>18 y/o
Who cannot join
- chronic lung disease female refuse to receive CPAP treatment or poor compliant to CPAP neurologic event
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Naitonal Taiwan Univerisity Hospital
Taipei, 100
Peilin Lee, M.D., +886-23562905, peilin1986@yahoo.com.tw
Peilin Lee, M.D.
About this study
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
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP
- Keywords
- Sleep apnea, Continuous positive airway pressure, Microarray, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP effect
Measured: 4-week after CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startFeb 2005
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peilin Lee, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498849
- Sponsor's protocol ID
- 9361701236
- Other IDs
- NSC 94-2314-B-002-218-
- Status last verified
- Jan 2005
- First submitted
- 8 Jul 2007
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Patterns of Microarray in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00498849
- Acronym / sponsor ID
- 9361701236
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, Continuous positive airway pressure, Microarray, Polysomnography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Dec 2007 (estimated)
- First posted
- 10 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy control with age > 18 y/o severe OSA (AHI>=30/hr) with age>18 y/o
Key exclusion criteria (1 listed)
- chronic lung disease female refuse to receive CPAP treatment or poor compliant to CPAP neurologic event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP | Device | – |
Primary outcome
CPAP effect
Time frame: 4-week after CPAP treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peilin Lee, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Sleep Apnea, Obstructive, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peilin Leee, M.D. (+886-2-23562905, peilin1986@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP effect (time frame: 4-week after CPAP treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2007.