search
Back to results

Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea (OSA) and Effect of 6-month CPAP Treatment

Primary Purpose

Sleep Apnea, Obstructive, Continuous Positive Airway Pressure, Endothelium

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Therapeutic CPAP
Subtherapeutic CPAP
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Cardiovascular disease, Continuous positive airway pressure, Endothelium, Vascular function, Inflammation, Sleep Apnea, Obstructive

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

OSA patients

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • sleepy driver
  • using maintenance medications

Control subjects

Inclusion Criteria:

  • Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
  • non-sleepy
  • no OSA confirmed by home sleep study (AHI<5/hr)

Exclusion Criteria:

  • 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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Sham Comparator

Arm Label

Healthy non-OSA control

OSA receiving therapeutic CPAP

OSA receiving subtherapeutic CPAP

Arm Description

Outcomes

Primary Outcome Measures

vascular reactivity of brachial artery and pulse wave velocity

Secondary Outcome Measures

percentage of adhesion molecule expression on monocytes
levels of extra and intracellular cytokine

Full Information

First Posted
March 8, 2011
Last Updated
December 12, 2016
Sponsor
National Taiwan University Hospital
Collaborators
China Medical University, China
search

1. Study Identification

Unique Protocol Identification Number
NCT01312168
Brief Title
Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea (OSA) and Effect of 6-month CPAP Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
China Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy non-OSA control
Arm Type
No Intervention
Arm Title
OSA receiving therapeutic CPAP
Arm Type
Experimental
Arm Title
OSA receiving subtherapeutic CPAP
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Therapeutic CPAP
Intervention Description
CPAP ventilator, optimal pressure decided by CPAP manual titration, daily use at sleep, six months
Intervention Type
Device
Intervention Name(s)
Subtherapeutic CPAP
Intervention Description
Subtherapeutic CPAP ventilator, pressure <3 cmH2O, daily use at sleep, six months
Primary Outcome Measure Information:
Title
vascular reactivity of brachial artery and pulse wave velocity
Time Frame
six months
Secondary Outcome Measure Information:
Title
percentage of adhesion molecule expression on monocytes
Time Frame
six months
Title
levels of extra and intracellular cytokine
Time Frame
six months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
OSA patients Inclusion Criteria: 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 Exclusion Criteria: 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 sleepy driver using maintenance medications Control subjects Inclusion Criteria: Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients non-sleepy no OSA confirmed by home sleep study (AHI<5/hr) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peilin Lee, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea (OSA) and Effect of 6-month CPAP Treatment

We'll reach out to this number within 24 hrs