Sleep Apnea, ObstructiveNCT01312168
Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea (OSA) and Effect of 6-month CPAP Treatment
A study testing Therapeutic CPAP and Subtherapeutic CPAP in people with Sleep Apnea, Obstructive and Continuous Positive Airway Pressure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This purpose of this study is to 1. Determine the change in endothelial dependent vascular reactivity and vascular properties 2. Determine the changes in monocytes activation 3. Determine the change in pro-inflammatory status 4. Investigate the effect of six-month CPAP therapy on the above changes in patients with OSA Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Endothelium
- What is being tested?
- Therapeutic CPAP and Subtherapeutic CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Feb 2017
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male patients aged 30 to 65 year who have daytime sleepiness (ESS>=10)
- newly diagnosed OSA (AHI>30/hr) by overnight PSG but never been treated
- Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
- non-sleepy
- no OSA confirmed by home sleep study (AHI<5/hr)
Who cannot join
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
Show all 20Show fewer
- enrolled in other trials in the study period
- other sleep disorders
- sleepy driver
- using maintenance medications
- Control subjects
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active neurologic event
- active infection two weeks prior to screening
- enrolled in other trials in the study period
- other sleep disorders
- using maintenance medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea and Effect of Six-month CPAP Treatment: A Large-scale, Double-blind, Randomized, Placebo-controlled Trial
This purpose of this study is to
- Determine the change in endothelial dependent vascular reactivity and vascular properties
- Determine the changes in monocytes activation
- Determine the change in pro-inflammatory status
- Investigate the effect of six-month CPAP therapy on the above changes in patients with OSA
Read the detailed description
Obstructive sleep apnea (OSA), characterized with chronic intermittent hypoxia (CIH) and sleep fragmentation, is associated with three-fold higher risk of cardiovascular events. CIH could promote production of ROS which induced the adhesion of circulating monocytes, endothelium injury, and production of pro-inflammatory mediators and adhesion molecules and lead to formation of atherosclerotic plaque. Recent studies showed vascular endothelium function could be noninvasively assessed with Flow-mediated dilation (FMD) in brachial artery, whereas OSA patients have lower FMD compared to control subjects. However, the CPAP effects on vascular function have conflicting results. Conflicts usually involve the small sample size, lack of appropriate control, and inadequate control of confounding factors, like physical activity, and duration of CPAP treatment. Also, CPAP effect on other monocytes activation and inflammatory mediators are clear as well. Our previous studies showed 12-week CPAP treatment could not modify the levels of TNF-α and hsCRP. However, the 12-week treatment may be not long enough to draw the conclusions for benefit from long-term CPAP therapy. Therefore, we plan to conduct a cross-sectional followed by a double blind, randomized, placebo-control, parallel-group interventional study to prove our hypothesis that OSA can lead to endothelial dysfunction, monocytes activation, and pro-inflammatory state which leads to and vasculopathy and those changes can be reverted by CPAP.
- Conditions
- Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Endothelium, Inflammation, Vascular Function
- Being tested
- Therapeutic CPAP, Subtherapeutic CPAP
- Keywords
- Cardiovascular disease, Continuous positive airway pressure, Endothelium, Vascular function, Inflammation, Sleep Apnea, Obstructive
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation, Cardiovascular Diseases, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic CPAPDevice
CPAP ventilator, optimal pressure decided by CPAP manual titration, daily use at sleep, six months
Subtherapeutic CPAPDevice
Subtherapeutic CPAP ventilator, pressure <3 cmH2O, daily use at sleep, six months
| Study group | Role | What they receive |
|---|---|---|
| Healthy non-OSA control | No intervention | Not described |
| OSA receiving therapeutic CPAP | Experimental | Not described Receives: Device: Therapeutic CPAP |
| OSA receiving subtherapeutic CPAP | Sham comparator | Not described Receives: Device: Subtherapeutic CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular reactivity of brachial artery and pulse wave velocity
Measured: six months
Secondary outcomes (2)
percentage of adhesion molecule expression on monocytes
Measured: six months
levels of extra and intracellular cytokine
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Sponsor
- Investigators
- Peilin Lee, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312168
- Sponsor's protocol ID
- 201012085RB
- Status last verified
- Dec 2016
- First submitted
- 8 Mar 2011
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea and Effect of Six-month CPAP Treatment: A Large-scale, Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01312168
- Acronym / sponsor ID
- 201012085RB
- Conditions
- Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Endothelium, Inflammation, Vascular Function
- Keywords
- Cardiovascular disease, Continuous positive airway pressure, Endothelium, Vascular function, Inflammation, Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- Mar 2011
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 10 Mar 2011 (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.
This purpose of this study is to
- Determine the change in endothelial dependent vascular reactivity and vascular properties
- Determine the changes in monocytes activation
- Determine the change in pro-inflammatory status
- Investigate the effect of six-month CPAP therapy on the above changes in patients with OSA
Detailed description
Obstructive sleep apnea (OSA), characterized with chronic intermittent hypoxia (CIH) and sleep fragmentation, is associated with three-fold higher risk of cardiovascular events. CIH could promote production of ROS which induced the adhesion of circulating monocytes, endothelium injury, and production of pro-inflammatory mediators and adhesion molecules and lead to formation of atherosclerotic plaque. Recent studies showed vascular endothelium function could be noninvasively assessed with Flow-mediated dilation (FMD) in brachial artery, whereas OSA patients have lower FMD compared to control subjects. However, the CPAP effects on vascular function have conflicting results. Conflicts usually involve the small sample size, lack of appropriate control, and inadequate control of confounding factors, like physical activity, and duration of CPAP treatment. Also, CPAP effect on other monocytes activation and inflammatory mediators are clear as well. Our previous studies showed 12-week CPAP treatment could not modify the levels of TNF-α and hsCRP. However, the 12-week treatment may be not long enough to draw the conclusions for benefit from long-term CPAP therapy. Therefore, we plan to conduct a cross-sectional followed by a double blind, randomized, placebo-control, parallel-group interventional study to prove our hypothesis that OSA can lead to endothelial dysfunction, monocytes activation, and pro-inflammatory state which leads to and vasculopathy and those changes can be reverted by CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy non-OSA control | No intervention | – |
| OSA receiving therapeutic CPAP | Experimental | Device: Therapeutic CPAP |
| OSA receiving subtherapeutic CPAP | Sham comparator | Device: Subtherapeutic CPAP |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male patients aged 30 to 65 year who have daytime sleepiness (ESS>=10)
- newly diagnosed OSA (AHI>30/hr) by overnight PSG but never been treated
- Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
- non-sleepy
- no OSA confirmed by home sleep study (AHI<5/hr)
Key exclusion criteria (20 listed)
- unwilling or unable to perform testing procedure
- past or current smoking history
- medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
- systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
- active 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 |
|---|---|---|
| Therapeutic CPAPCPAP ventilator, optimal pressure decided by CPAP manual titration, daily use at sleep, six months | Device | OSA receiving therapeutic CPAP |
| Subtherapeutic CPAPSubtherapeutic CPAP ventilator, pressure <3 cmH2O, daily use at sleep, six months | Device | OSA receiving subtherapeutic CPAP |
Primary outcome
vascular reactivity of brachial artery and pulse wave velocity
Time frame: six months
2 secondary outcomes
percentage of adhesion molecule expression on monocytes
Time frame: six months
levels of extra and intracellular cytokine
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
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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 Therapeutic CPAP and Subtherapeutic CPAP in people with Sleep Apnea, Obstructive and Continuous Positive Airway Pressure, 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 5 inclusion and 20 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 14 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular reactivity of brachial artery and pulse wave velocity (time frame: six months). 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 14 Dec 2016.