The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
Primary Purpose
Hypertension, Metabolic Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring continuous positive airway pressure, hypertension, coronary heart disease, metabolic disorder, obstructive sleep apnea
Eligibility Criteria
Inclusion Criteria:
- men and women, aged 45 to 75 years old
- verified diagnosis of hypertension by medical history or receiving antihypertensive drugs
- established diagnosis of CHD
- at least 3-month optimal treatment for hypertension
- moderate or severe OSA
Exclusion Criteria:
- if they had secondary hypertension
- central sleep apneas
- history of significant chronic renal, or hepatic failure or severe pulmonary disease
- diagnosed with malignant cancer with a life expectancy of less than 2years
- regular use of medications that can affect BP(including corticosteroids or sedative drugs)
- severe psychiatric disease
- sustained excessive alcohol use
- current use of CPAP treatment for OSA or pharyngeal surgery for OSA
- New York Heart Association Class III-IV degree
- declined to participate or were unable to give informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
continuous positive airway pressure
Control
Arm Description
mean continuous positive airway pressure use was at least 4 hours per night; continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure
The control subjects received standardised anti-hypertension medications according to the current guildline.
Outcomes
Primary Outcome Measures
Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment
Secondary Outcome Measures
Change in Epworth Sleepiness Scale (ESS)
The epworth sleepiness scale(ESS) measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness.
Full Information
NCT ID
NCT02059993
First Posted
February 9, 2014
Last Updated
July 14, 2020
Sponsor
Chinese Pulmonary Vascular Disease Research Group
1. Study Identification
Unique Protocol Identification Number
NCT02059993
Brief Title
The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
Official Title
The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (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
Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease.The standardized treatment of moderate/severe OSA is continuous positive airway pressure (CPAP). Most of short-term trials indicated that CPAP treatment reduced BP in patients with OSA. But relevant studies have a relative short duration with only but few more than one year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP. Besides, the impact of OSA on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could reduce blood pressure and improve metabolic disorder in patients with coronary heart disease (CHD)and OSA.
Detailed Description
Obstructive sleep apnea (OSA) is a common disorder characterized by repetitive partial (hypopnea) or complete (apnea) occlusion of the upper airway during sleep caused by collapse of the pharyngeal airway, resulting in sleep fragmentation and oxyhemoglobin desaturation. Kiely and colleague's study showed that over 20% of hypertensive patients exhibit OSA, whereas prevalence of hypertension in the setting of OSA exceeds 50%. One study confirmed that OSA is an important identifiable cause of hypertension. OSA is considered as one of the most common risk factors of resistant hypertension. Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease. Several studies confirmed that CPAP reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with OSA. Additionally, some papers reported that there was a protective effect of CPAP therapy against death from cardiovascular disease in patients with severe OSA. Other researches regarding the antihypertensive effect of CPAP therapy, however, showed that CPAP had no antihypertensive effect. But relevant studies have a relative short duration with only but few more than one year. In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP. According to our knowledge, there is no report about long-term effect of CPAP on BP in hypertensive patients with coronary revascularization (CRV) and OSA under conventional antihypertensive medications. Therefore, we conducted a long-term, prospective controlled study to investigate the effects of CPAP on BP, metabolic disorder, clinical symptoms, cardiovascular and cerebrovascular events in patients with CHD and OSA on conventional treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Disorder
Keywords
continuous positive airway pressure, hypertension, coronary heart disease, metabolic disorder, obstructive sleep apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous positive airway pressure
Arm Type
Other
Arm Description
mean continuous positive airway pressure use was at least 4 hours per night; continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control subjects received standardised anti-hypertension medications according to the current guildline.
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure
Intervention Description
mean continuous positive airway pressure use was at least 4 hours per night;continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure
Primary Outcome Measure Information:
Title
Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment
Time Frame
baseline and follow-up at 36 months
Secondary Outcome Measure Information:
Title
Change in Epworth Sleepiness Scale (ESS)
Description
The epworth sleepiness scale(ESS) measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations. The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness.
Time Frame
baseline,end of study ( up to 54 months)
Other Pre-specified Outcome Measures:
Title
Cardiovascular and Cerebrovascular Events
Time Frame
Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month
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:
men and women, aged 45 to 75 years old
verified diagnosis of hypertension by medical history or receiving antihypertensive drugs
established diagnosis of CHD
at least 3-month optimal treatment for hypertension
moderate or severe OSA
Exclusion Criteria:
if they had secondary hypertension
central sleep apneas
history of significant chronic renal, or hepatic failure or severe pulmonary disease
diagnosed with malignant cancer with a life expectancy of less than 2years
regular use of medications that can affect BP(including corticosteroids or sedative drugs)
severe psychiatric disease
sustained excessive alcohol use
current use of CPAP treatment for OSA or pharyngeal surgery for OSA
New York Heart Association Class III-IV degree
declined to participate or were unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD,PhD
Organizational Affiliation
Fuwai Hospital, National Center for Cardiovascular Diseases
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
25125635
Citation
Huang Z, Liu Z, Luo Q, Zhao Q, Zhao Z, Ma X, Liu W, Yang D. Long-term effects of continuous positive airway pressure on blood pressure and prognosis in hypertensive patients with coronary heart disease and obstructive sleep apnea: a randomized controlled trial. Am J Hypertens. 2015 Mar;28(3):300-6. doi: 10.1093/ajh/hpu147. Epub 2014 Aug 14.
Results Reference
derived
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The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
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