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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
Chinese Pulmonary Vascular Disease Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

    First Posted
    February 9, 2014
    Last Updated
    July 14, 2020
    Sponsor
    Chinese Pulmonary Vascular Disease Research Group
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    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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