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
About this trial
This is an interventional supportive care trial for OSA
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
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
NCT ID
NCT05237505
First Posted
February 2, 2022
Last Updated
June 1, 2023
Sponsor
University of California, San Diego
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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