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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127177
• Other study ID #: SF2009
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: April 28, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Chinese Pulmonary Vascular Disease Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure Ventilator
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.

Locations

Country	Name	City	State
China	center of pulmonary vascular disease, Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lipid profiles	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	No
Secondary	High-sensitivity C-reactive protein	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	No