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Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients

Primary Purpose

Obstructive Sleep Apnea, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure Ventilator
Sponsored by
Chinese Pulmonary Vascular Disease Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, coronary heart disease, continuous positive airway pressure, lipid profiles, high-sensitivity C-reactive protein

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants diagnosed with a confirmation of CHD and moderate to severe

Exclusion Criteria:

  • A body mass index (BMI) ≥ 25 kg/m2
  • Established hypertension, diabetes mellitus, predominantly central sleep apnea, hypothyroidism
  • A history of smoking, chronic obstructive pulmonary disease, atopy, rhinitis, arthritis
  • Pharmacological treatment that could affect lipids and hs-CRP levels
  • Epworth Sleepiness Scale (ESS) ≥15
  • Diagnosed with malignant cancer with a life expectancy of less than 1 years
  • Severe psychiatric disease, sustained excessive alcohol use, New York Heart Association Class III-IV degree
  • Declined to participate or were unable to give informed consent.

Sites / Locations

  • center of pulmonary vascular disease, Fuwai hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cpap

No Cpap

Arm Description

Outcomes

Primary Outcome Measures

lipid profiles
plasma fasting lipid profiles were measured at baseline, 6months,and 12months.

Secondary Outcome Measures

High-sensitivity C-reactive protein
Fasting plasma high-sensitivity C-reactive protein was analyzed at baseline,6 months,and 12 months.

Full Information

First Posted
April 24, 2014
Last Updated
April 28, 2014
Sponsor
Chinese Pulmonary Vascular Disease Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT02127177
Brief Title
Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients
Official Title
Long-term Effects of Continuous Positive Airway Pressure on Lipidemia and High-sensitivity C-reactive Protein Levels in Nonobese Patients With Coronary Heart Disease and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Pulmonary Vascular Disease Research Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and systemic inflammation. The relationship regarding obstructive sleep apnea (OSA) and lipidemia and systemic inflammation is far from conclusion for obesity as a strong confounding factor.
Detailed Description
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep, resulting in sleep fragmentation and oxyhemoglobin desaturation. OSA is recognized as an important public health problem in developed country, affecting 9 and 24% of middle-aged females and males, respectively. OSA, however, is not recognized as an abnormality for the majority and doesn't get more attention from most people in China. Increasing evidence now indicates that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke. Atherosclerosis is a key mechanism for these cardiovascular events. Numerous studies have explored the relationship between hypertension and OSA. And these studies confirms that OSA is an important identifiable cause of hypertension and a raised blood pressure has been shown to fall with effective continuous positive airway pressure (CPAP) treatment. Dyslipidemia, an established independent risk factor for coronary heart disease (CHD) and atherosclerosis, is common in patients with OSA. But there are limited interventional data on OSA and lipidemia, showing controversial results. Several studies9,10 have shown a direct relationship between OSA and lipid profiles, independently of obesity, while other studies have demonstrated that obesity, as a confounding factor, contributed to dyslipidemia among OSA patients.11,12 Taken together, adiposity is a strong confounding factor for interpretation of the causal relationship between dyslipidemia and OSA. Few studies have focused on nonobese patients.10,13 There are only a small number of randomized trials that have examined the effect of CPAP on fasting lipid profiles14,15 and none were specifically designed to evaluate the lipid profiles. Furthermore, most studies assessed the impact of CPAP on OSA-related lipids without statin therapy. In this way, it may be useful to avoid the disturb conditions due to statin treatment. But it is impractical to those patients with OSA and CHD. Since statins, in addition to decreasing hyperlipidemia levels, also inhibit inflammatory cytokines and play a critical role of plaque stabilization in CHD patients. Similarly, the condition existed in the examination of high-sensitivity C-reactive protein (hs-CRP) in CHD subjects with OSA. Therefore, the aims of the present study were (1) to establish whether CPAP therapy decreases lipid profiles and hs-CRP levels in nonobese patients with CHD and OSA, (2) to establish whether a relationship exists between the severity of OSA and levels of these circulating markers, and (3) to demonstrate a possible mechanism for the prevention of cardiovascular disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Coronary Heart Disease
Keywords
obstructive sleep apnea, coronary heart disease, continuous positive airway pressure, lipid profiles, high-sensitivity C-reactive protein

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cpap
Arm Type
Experimental
Arm Title
No Cpap
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure Ventilator
Other Intervention Name(s)
Continuous Positive Airway Pressure(CPAP)
Intervention Description
CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night, according to a previous validation by our study.
Primary Outcome Measure Information:
Title
lipid profiles
Description
plasma fasting lipid profiles were measured at baseline, 6months,and 12months.
Time Frame
baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
Secondary Outcome Measure Information:
Title
High-sensitivity C-reactive protein
Description
Fasting plasma high-sensitivity C-reactive protein was analyzed at baseline,6 months,and 12 months.
Time Frame
baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with a confirmation of CHD and moderate to severe Exclusion Criteria: A body mass index (BMI) ≥ 25 kg/m2 Established hypertension, diabetes mellitus, predominantly central sleep apnea, hypothyroidism A history of smoking, chronic obstructive pulmonary disease, atopy, rhinitis, arthritis Pharmacological treatment that could affect lipids and hs-CRP levels Epworth Sleepiness Scale (ESS) ≥15 Diagnosed with malignant cancer with a life expectancy of less than 1 years Severe psychiatric disease, sustained excessive alcohol use, New York Heart Association Class III-IV degree Declined to participate or were unable to give informed consent.
Facility Information:
Facility Name
center of pulmonary vascular disease, Fuwai hospital
City
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26804247
Citation
Huang Z, Liu Z, Zhao Z, Zhao Q, Luo Q, Tang Y. Effects of Continuous Positive Airway Pressure on Lipidaemia and High-sensitivity C-reactive Protein Levels in Non-obese Patients with Coronary Artery Disease and Obstructive Sleep Apnoea. Heart Lung Circ. 2016 Jun;25(6):576-83. doi: 10.1016/j.hlc.2015.10.021. Epub 2016 Jan 4.
Results Reference
derived

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Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients

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