Race And CPAP Effectiveness (RACE)
Primary Purpose
Sleep Apnea Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring CPAP treatment, hypertension
Eligibility Criteria
Inclusion Criteria:
- Self-identified African American and other Veterans (of self-identified race other than African American)
- Age: 30-70 years
- Hypertension
- Apnea hypopnea index (AHI) 15/hour on home sleep apnea test
Exclusion Criteria:
- Past/current treatment of Obstructive Sleep Apnea or other primary sleep disorders
- Active uncontrolled medical conditions
- Shift work in past 6 months
- Current drug use
- Pregnancy
Sites / Locations
- Jesse Brown VA Medical Center, Chicago, IL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
African Americans
non African Americans
Arm Description
138 Self identified African American
53 Caucasians and 29 Other race (non African-Americans) Veterans.
Outcomes
Primary Outcome Measures
24 Hour Ambulatory Blood Pressure
Mean systolic and diastolic blood pressure measured over 24 hours with ambulatory monitor (Spacelabs).
The change in blood pressure values were calculated as 3 months BP - baseline BP.
The mean and standard deviation in the sample are noted below.
Secondary Outcome Measures
Central Aortic Blood Pressure
Central aortic blood pressure (CABP) measured noninvasively with a cuff (SphygmoCor XCEL).
The change in CABP values were calculated as 3 months CABP - baseline CABP. The mean and standard deviation in the sample are noted below.
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)
Urine samples from participants over 24 hours will be analyzed for catecholamines and overnight sample will be partitioned for measurement of oxidative stress.
The change in urine catecholamine values were calculated as 3 months - baseline.
The mean and standard deviation in the sample are noted below.
Full Information
NCT ID
NCT01960465
First Posted
September 9, 2013
Last Updated
October 28, 2020
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01960465
Brief Title
Race And CPAP Effectiveness
Acronym
RACE
Official Title
Targeted Treatment of Obstructive Sleep Apnea to Reduce Cardiovascular Disparity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2015 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obstructive sleep apnea (OSA) is a major public health problem in the U.S. and more than 35% of Veterans are at high risk for OSA. OSA is associated with progression of hypertension, an important health problem in Veterans. African Americans with OSA are at increased risk for poorly controlled hypertension and its health consequences. Implementing a care plan to increase the percentage of Veterans in whom blood pressure goals are achieved has been prioritized by Veterans Administration hospitals. Recent studies show that hypertension control can be improved with continuous positive airway pressure (CPAP) treatment of OSA. The aim of this proposal is to examine and compare the effects of CPAP treatment on 24-hour arterial blood pressure and central aortic blood pressure (measured non-invasively with a cuff on the upper arm) in African American and other Veterans.
Detailed Description
Obstructive Sleep Apnea (OSA) and hypertension are both common and severe problems in African American individuals (as noted in the International Society on Hypertension in Blacks consensus statement). CPAP treatment of OSA is effective in controlling hypertension in patients with OSA, but has not been studied in African Americans, a high-risk population with potentially large health gains. This is an area of significance because poorly controlled hypertension leads to progression of cardiovascular disease (CVD) and morbidity in this population. By identifying CPAP treatment-response and relevant moderators of this response in African Americans with hypertension and OSA, targeted treatment of OSA can be implemented, reducing the excess burden of CVD. The investigators will determine the relative magnitude of hypertension response to CPAP treatment (ambulatory blood pressure and central aortic blood pressure) in 220 African American and Veterans of other race(s) with hypertension and newly diagnosed OSA (specific aim 1). The investigators will measure changes in pathogenic biomarkers (urinary cumulative sympathetic nervous system activity and oxidative stress) that are responsive to CPAP treatment in addition to hypertension assessments. Further, the investigators will examine the role of excessive daytime sleepiness (EDS), a potentially important moderator of treatment response, in these two patient populations (specific aim 2). Finally, the investigators will adjust the outcomes assessment for the anticipated biological heterogeneity among self-identified African Americans by measuring genetic ancestry (exploratory aim). This award will provide the foundation for the goals of this research program to reduce CVD disparity in diverse populations with targeted treatment of OSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
CPAP treatment, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
African Americans
Arm Type
Experimental
Arm Description
138 Self identified African American
Arm Title
non African Americans
Arm Type
Active Comparator
Arm Description
53 Caucasians and 29 Other race (non African-Americans) Veterans.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
Primary Outcome Measure Information:
Title
24 Hour Ambulatory Blood Pressure
Description
Mean systolic and diastolic blood pressure measured over 24 hours with ambulatory monitor (Spacelabs).
The change in blood pressure values were calculated as 3 months BP - baseline BP.
The mean and standard deviation in the sample are noted below.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Central Aortic Blood Pressure
Description
Central aortic blood pressure (CABP) measured noninvasively with a cuff (SphygmoCor XCEL).
The change in CABP values were calculated as 3 months CABP - baseline CABP. The mean and standard deviation in the sample are noted below.
Time Frame
3 months
Title
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)
Description
Urine samples from participants over 24 hours will be analyzed for catecholamines and overnight sample will be partitioned for measurement of oxidative stress.
The change in urine catecholamine values were calculated as 3 months - baseline.
The mean and standard deviation in the sample are noted below.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-identified African American and other Veterans (of self-identified race other than African American)
Age: 30-70 years
Hypertension
Apnea hypopnea index (AHI) 15/hour on home sleep apnea test
Exclusion Criteria:
Past/current treatment of Obstructive Sleep Apnea or other primary sleep disorders
Active uncontrolled medical conditions
Shift work in past 6 months
Current drug use
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bharati Prasad, MD
Organizational Affiliation
Jesse Brown VA Medical Center, Chicago, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34931603
Citation
Imayama I, Gupta A, Yen PS, Chen YF, Keenan B, Townsend RR, Chirinos JA, Weaver FM, Carley DW, Kuna ST, Prasad B. Socioeconomic status impacts blood pressure response to positive airway pressure treatment. J Clin Sleep Med. 2022 May 1;18(5):1287-1295. doi: 10.5664/jcsm.9844.
Results Reference
derived
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Race And CPAP Effectiveness
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