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The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

Primary Purpose

OSA, COPD, Overlap Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bi-Level Positive Airway Pressure
Oxygen gas
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for OSA

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 24-32
  • OSA
  • COPD

Exclusion Criteria:

  • Medically unstable individuals with significant neurological disease
  • Smokers
  • Cardiovascular disease
  • Epworth Sleepiness score over 18
  • Kidney Disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Arm Label

    Obstructive Sleep Apnea

    Chronic Obstructive Pulmonary Disease

    Overlap Syndrome

    Arm Description

    OSA + COPD

    Outcomes

    Primary Outcome Measures

    Flow-mediated dilation (FMD)
    Brachial artery flow-mediated vasodilation (FMD, endothelium-dependent vasodilation). Highresolution brachial artery ultrasound, consisting of images taken at rest and during reactive hyperemia, will be performed under fasting conditions according to established guidelines.
    Right ventricular mass
    Cardiac magnet resonance imaging (CMR) measurements will be obtained the same day participants undergo the evaluation of vascular reactivity measurements. Supine CMR imaging will be performed using a 3T MR scanner (GE 750, GE Healthcare) with a 16-element cardiac coil for radiofrequency signal reception.
    5th generation troponin
    Biomarkers levels, such as troponin and miR-210, will be measured from participant serum samples.
    mir-210
    Biomarkers levels, such as troponin and miR-210, will be measured from participant serum samples.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2022
    Last Updated
    June 1, 2023
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05237505
    Brief Title
    The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
    Official Title
    The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2027 (Anticipated)
    Study Completion Date
    August 31, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim 1: The Investigators will perform a cross-sectional study to examine vascular risk in individuals with OVS compared with matched individuals with OSA alone or COPD alone. The PI will examine a panel of biomarkers including cardiac magnetic resonance imaging (right ventricular mass primary outcome), flow mediated vasodilation, plasma biomarkers (BNP, troponin, hsCRP, ST2, galectin3, miR-210). This aim will allow the team to test the hypothesis that individuals with OVS have increased vascular risk compared with matched individuals with OSA alone or COPD alone. This aim will also allow the team to compare the magnitude of the effect of OSA vs. COPD vs OVS for design of subsequent basic and clinical studies. Aim 2: The Investigators will perform an interventional study in individuals with OVS to compare the impact of bi-level therapy with that of oxygen therapy (the current standard of care). The team will assess the same panel of biomarkers as in Aim 1 to determine the impact of treatment on the observed abnormalities. This aim will allow the team to test the hypothesis that bi-level therapy is superior to oxygen in the treatment of individuals with OVS from the standpoint of right ventricular mass and other cardiovascular risk parameters/outcomes. Our assessments of biomarkers will help to define potential causal pathways for our findings and will allow determination of appropriate biomarkers for subsequent multicenter studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    OSA, COPD, Overlap Syndrome, Sleep Apnea, Sleep, Obstructive Sleep Apnea

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Qualified participants will be randomized to receive either O2 therapy or bi-level therapy.
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Obstructive Sleep Apnea
    Arm Type
    No Intervention
    Arm Title
    Chronic Obstructive Pulmonary Disease
    Arm Type
    No Intervention
    Arm Title
    Overlap Syndrome
    Arm Type
    Experimental
    Arm Description
    OSA + COPD
    Intervention Type
    Device
    Intervention Name(s)
    Bi-Level Positive Airway Pressure
    Intervention Description
    6 months of Bi-Level positive airway pressure therapy starting at 8cmH2O inspiratory pressure/4 cmH2O expiratory pressure titrated until subject until the subject reaches a minimum, stable breathing pattern and blood oxygen saturation of 88%. If stability in blood oxygen content is not met using these parameters, supplemental oxygen may be added.
    Intervention Type
    Drug
    Intervention Name(s)
    Oxygen gas
    Intervention Description
    6 Months of Oxygen starting a minimum flow of 2 litres per minute, titrated up until the subject reaches a minimum, stable blood oxygen saturation of 88%
    Primary Outcome Measure Information:
    Title
    Flow-mediated dilation (FMD)
    Description
    Brachial artery flow-mediated vasodilation (FMD, endothelium-dependent vasodilation). Highresolution brachial artery ultrasound, consisting of images taken at rest and during reactive hyperemia, will be performed under fasting conditions according to established guidelines.
    Time Frame
    6 Months
    Title
    Right ventricular mass
    Description
    Cardiac magnet resonance imaging (CMR) measurements will be obtained the same day participants undergo the evaluation of vascular reactivity measurements. Supine CMR imaging will be performed using a 3T MR scanner (GE 750, GE Healthcare) with a 16-element cardiac coil for radiofrequency signal reception.
    Time Frame
    6 months
    Title
    5th generation troponin
    Description
    Biomarkers levels, such as troponin and miR-210, will be measured from participant serum samples.
    Time Frame
    6 months
    Title
    mir-210
    Description
    Biomarkers levels, such as troponin and miR-210, will be measured from participant serum samples.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI 24-32 OSA COPD Exclusion Criteria: Medically unstable individuals with significant neurological disease Smokers Cardiovascular disease Epworth Sleepiness score over 18 Kidney Disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pamela DeYoung, BA
    Phone
    8582462183
    Email
    pdeyoung@health.ucsd.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Atul Malhotra, MD
    Organizational Affiliation
    UCSD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

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