Sleep Apnea, ObstructiveNCT00498732
Dissection of Differentially Expressed Genes and Pathways in Patients With OSAS Before and After CPAP Treatment
An observational study of Sleep Apnea, Obstructive, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Specific Aim 1. To verify the differentially expressed genes and pathways between normal and OSA patients, and OSA patients before and after CPAP treatment. Genes with changes in expression of more than two-fold between normal and OSA patients as well as OSA patients before and after CPAP treatment were thought as… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2007to Jul 2008
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: From patients who were referred to sleep lab for suspect sleep apnea, we selected 50 male patients with age> 18 y/o. with severe OSAS, which were confirmed with by overnight PSG. All were free from neurologic events, chronic pulmonary disease, active infection and substance abuse. Female patients and patients under 18 y/o were excluded. All 50 subjects were treated with 4-week CPAP. All study subjects were admitted, on the day of baseline measurement and four weeks after CPAP use, for clinical evaluation, blood sampling and PSG. And all anti-hypertensive therapy was remained unchanged during the 4-week follow-up period. Changes of parameters, before and after CPAP treatment, were compared between two groups.
Who may be able to join
- Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject
Who cannot join
- Refused to participate in this study
- Had severe obstructive pulmonary disease or active neurological events
- Enrolled in other studies at the same time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissection of Differentially Expressed Genes and Pathways in Patients With Obstructive Sleep Apnea Syndrome Before and After CPAP Treatment
Specific Aim
- To verify the differentially expressed genes and pathways between normal and OSA patients, and OSA patients before and after CPAP treatment. Genes with changes in expression of more than two-fold between normal and OSA patients as well as OSA patients before and after CPAP treatment were thought as confirmed and were selected for further validation study.
- To correlate the confirmed genes with the clinical presentations and CPAP effects in another 50 OSAS subjects to validate the altered gene expressions and pathways involved. To investigate the correlation of genes confirmed from RT-PCR (identified gene), another 50 OSAS subjects are included in the study. We analyze the correlation between identified gene and the clinical manifestations and CPAP effect in these 50 OSAS patients.
- To establish a cell model to investigate the differentially expressed genes and the putative biological pathways involved in OSA syndrome.
Read more
To investigate the functions of genes identified in the first and second year (gene of interest), we establish a cell model with human monocyte cell line U937. We investigate the function of gene of interest through overexpress or knockdown.
Objectives The objectives of this project are to confirm the gene profiled from comparing normal and OSA patients as well as OSA patients before and after CPAP treatment, to investigate the correlation between altered gene expression and clinical presentations and CPAP effects of the OSAS and to identify and confirm corresponding pathway. This study will enhance our understanding of the individual constitution on widely different clinical characteristics and therapeutic variations. All these efforts will also help us to interpret its molecular mechanisms and develop prediction and diagnosis strategies of OSAS. The long-term objectives are to develop therapeutic strategy other than CPAP of OSAS.
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, which resulted in cardiovascular diseases, metabolic disorders and neurocognitive dysfunctions. The cardiovascular complications attributed to OSAS included hypertension, coronary artery disease, heart failure and stroke. The mechanisms responsible for developments of cardiovascular sequelae included repeated episodes of hypoxia and hypercapnia, exaggerated negative intrathoracic pressure and bursts of sympathetic activity provoking surges in blood pressure and heart rate. 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.
To clarify the exact mechanisms of OSAS and the linkage to cardiovascular complications, in our previous study, we used oligo microarray to genome-wide profile the gene expression patterns in OSAS patients and the changes of gene expressions before and after four-week CPAP treatment. The oligo-microarray data were processed with CRSD database and two-way hierarchical clustering method. The results showed the gene expression patterns were different between control subjects and OSA patients and CPAP treatment also altered the gene expression patterns. Totally 27 genes and four pathways were identified as target genes and pathways from comparing the gene pattern changes before and after CPAP treatment, which included apoptosis, oxidative phosphorylation, cell adhesion and activation and metabolism. To continue analyzing the gene pattern changes before and after CPAP treatment, we propose this three-year project to achieve the following goals: (1) To verify the differentially expressed genes and pathways between normal and OSA patients, and OSA patients before and after CPAP treatment. (2) To correlate the confirmed genes with the clinical presentations and CPAP effects in another 50 OSAS subjects to validate the altered gene expressions and pathways involved. (3) To establish a cell model to investigate the differentially expressed genes and the putative biological pathways involved in OSA syndrome. The information obtained by this approach is very useful to understand the pathogenic mechanism of OSA that leads to systemic complications and further therapeutic intervention may therefore be possible.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP
- Keywords
- Obstructive sleep apnea syndrome; CPAP, microarray
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP treatment for 4 weeks
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 startJun 2007
- Primary completionMar 2008
- Study completionJul 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT00498732
- Sponsor's protocol ID
- 200701064R
- Status last verified
- Nov 2010
- First submitted
- 8 Jul 2007
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissection of Differentially Expressed Genes and Pathways in Patients With Obstructive Sleep Apnea Syndrome Before and After CPAP Treatment
- ClinicalTrials.gov ID
- NCT00498732
- Acronym / sponsor ID
- 200701064R
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apnea syndrome; CPAP, microarray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jul 2008 (actual)
- 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.
Specific Aim
- To verify the differentially expressed genes and pathways between normal and OSA patients, and OSA patients before and after CPAP treatment. Genes with changes in expression of more than two-fold between normal and OSA patients as well as OSA patients before and after CPAP treatment were thought as confirmed and were selected for further validation study.
- To correlate the confirmed genes with the clinical presentations and CPAP effects in another 50 OSAS subjects to validate the altered gene expressions and pathways involved. To investigate the correlation of genes confirmed from RT-PCR (identified gene), another 50 OSAS subjects are included in the study. We analyze the correlation between identified gene and the clinical manifestations and CPAP effect in these 50 OSAS patients.
- To establish a cell model to investigate the differentially expressed genes and the putative biological pathways involved in OSA syndrome.
To investigate the functions of genes identified in the first and second year (gene of interest), we establish a cell model with human monocyte cell line U937. We investigate the function of gene of interest through overexpress or knockdown.
Objectives The objectives of this project are to confirm the gene profiled from comparing normal and OSA patients as well as OSA patients before and after CPAP treatment, to investigate the correlation between altered gene expression and clinical presentations and CPAP effects of the OSAS and to identify and confirm corresponding pathway. This study will enhance our understanding of the individual constitution on widely different clinical characteristics and therapeutic variations. All these efforts will also help us to interpret its molecular mechanisms and develop prediction and diagnosis strategies of OSAS. The long-term objectives are to develop therapeutic strategy other than CPAP of OSAS.
Detailed description
Obstructive sleep apnea syndrome (OSAS) is characterized with recurrent collapse of upper airway during sleep and resulted in hypoxia and sleep fragmentation, which resulted in cardiovascular diseases, metabolic disorders and neurocognitive dysfunctions. The cardiovascular complications attributed to OSAS included hypertension, coronary artery disease, heart failure and stroke. The mechanisms responsible for developments of cardiovascular sequelae included repeated episodes of hypoxia and hypercapnia, exaggerated negative intrathoracic pressure and bursts of sympathetic activity provoking surges in blood pressure and heart rate. 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.
To clarify the exact mechanisms of OSAS and the linkage to cardiovascular complications, in our previous study, we used oligo microarray to genome-wide profile the gene expression patterns in OSAS patients and the changes of gene expressions before and after four-week CPAP treatment. The oligo-microarray data were processed with CRSD database and two-way hierarchical clustering method. The results showed the gene expression patterns were different between control subjects and OSA patients and CPAP treatment also altered the gene expression patterns. Totally 27 genes and four pathways were identified as target genes and pathways from comparing the gene pattern changes before and after CPAP treatment, which included apoptosis, oxidative phosphorylation, cell adhesion and activation and metabolism. To continue analyzing the gene pattern changes before and after CPAP treatment, we propose this three-year project to achieve the following goals: (1) To verify the differentially expressed genes and pathways between normal and OSA patients, and OSA patients before and after CPAP treatment. (2) To correlate the confirmed genes with the clinical presentations and CPAP effects in another 50 OSAS subjects to validate the altered gene expressions and pathways involved. (3) To establish a cell model to investigate the differentially expressed genes and the putative biological pathways involved in OSA syndrome. The information obtained by this approach is very useful to understand the pathogenic mechanism of OSA that leads to systemic complications and further therapeutic intervention may therefore be possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- From patients who were referred to sleep lab for suspect sleep apnea, we selected 50 male patients with age> 18 y/o. with severe OSAS, which were confirmed with by overnight PSG. All were free from neurologic events, chronic pulmonary disease, active infection and substance abuse. Female patients and patients under 18 y/o were excluded. All 50 subjects were treated with 4-week CPAP. All study subjects were admitted, on the day of baseline measurement and four weeks after CPAP use, for clinical evaluation, blood sampling and PSG. And all anti-hypertensive therapy was remained unchanged during the 4-week follow-up period. Changes of parameters, before and after CPAP treatment, were compared between two groups.
Key inclusion criteria (1 listed)
- Severe obstructive sleep apnea (AHI>=30/hr) age, sex, BMI match control subject
Key exclusion criteria (3 listed)
- Refused to participate in this study
- Had severe obstructive pulmonary disease or active neurological events
- Enrolled in other studies at the same time
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 |
|---|---|---|
| CPAPCPAP treatment for 4 weeks | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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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?
An observational study of 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 3 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: finished, as of the sponsor's last update on 1 Dec 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 1 Dec 2010.