- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127177
Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients
April 28, 2014 updated by: Chinese Pulmonary Vascular Disease Research Group
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100037
- Center of pulmonary vascular disease, Fuwai hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cpap
|
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.
Other Names:
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No Intervention: No Cpap
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lipid profiles
Time Frame: baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
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plasma fasting lipid profiles were measured at baseline, 6months,and 12months.
|
baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High-sensitivity C-reactive protein
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
|
Fasting plasma high-sensitivity C-reactive protein was analyzed at baseline,6 months,and 12 months.
|
baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 24, 2014
First Submitted That Met QC Criteria
April 28, 2014
First Posted (Estimate)
April 30, 2014
Study Record Updates
Last Update Posted (Estimate)
April 30, 2014
Last Update Submitted That Met QC Criteria
April 28, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Lipid Metabolism Disorders
- Dyslipidemias
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Hyperlipidemias
Other Study ID Numbers
- SF2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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