Skip to content

Race And CPAP Effectiveness

Targeted Treatment of Obstructive Sleep Apnea to Reduce Cardiovascular Disparity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960465
Acronym
RACE
Enrollment
220
Registered
2013-10-10
Start date
2015-01-05
Completion date
2019-08-30
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

CPAP treatment, hypertension

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.

Interventions

DEVICEContinuous positive airway pressure

A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
24 Hour Ambulatory Blood Pressure3 monthsMean 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

MeasureTime frameDescription
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)3 monthsUrine 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.
Central Aortic Blood Pressure3 monthsCentral 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.

Countries

United States

Participant flow

Recruitment details

January 2015 to August 2019, recruitment by chart review (results of home sleep apnea test) at Jesse Brown VA. Participants were contacted by phone, consented on screening/Visit 1.

Pre-assignment details

All participants had moderate to severe newly diagnosed/untreated OSA\> They were started on PAP therapy after visit 1.

Participants by arm

ArmCount
African Americans
138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
138
Non African Americans
53 Caucasians and 29 Other race (non African-Americans) Veterans. Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
82
Total220

Baseline characteristics

CharacteristicTotalNon African AmericansAfrican Americans
24 hour blood pressure129.02 mm Hg
STANDARD_DEVIATION 13.9
126.49 mm Hg
STANDARD_DEVIATION 13.6
130.55 mm Hg
STANDARD_DEVIATION 13.9
Age, Continuous53.5 years
STANDARD_DEVIATION 10.3
53.1 years
STANDARD_DEVIATION 10.4
53.74 years
STANDARD_DEVIATION 10.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
138 Participants0 Participants138 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
29 Participants29 Participants0 Participants
Race (NIH/OMB)
White
53 Participants53 Participants0 Participants
Region of Enrollment
United States
220 participants82 participants138 participants
Sex: Female, Male
Female
26 Participants9 Participants17 Participants
Sex: Female, Male
Male
194 Participants73 Participants121 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1380 / 82
other
Total, other adverse events
0 / 1380 / 82
serious
Total, serious adverse events
0 / 1380 / 82

Outcome results

Primary

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.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
African Americans24 Hour Ambulatory Blood PressureSystolic BP-1.93 mm HgStandard Deviation 13
African Americans24 Hour Ambulatory Blood PressureDiastolic BP-1.38 mm HgStandard Deviation 9.3
Non African Americans24 Hour Ambulatory Blood PressureSystolic BP-0.64 mm HgStandard Deviation 7.6
Non African Americans24 Hour Ambulatory Blood PressureDiastolic BP-1.19 mm HgStandard Deviation 7.9
Secondary

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.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
African AmericansCentral Aortic Blood PressurePulse Wave Velocity-0.20 m/sec and percentStandard Deviation 2
African AmericansCentral Aortic Blood PressureAugmentation Index-1.20 m/sec and percentStandard Deviation 10.6
Non African AmericansCentral Aortic Blood PressurePulse Wave Velocity-0.23 m/sec and percentStandard Deviation 1.6
Non African AmericansCentral Aortic Blood PressureAugmentation Index-0.68 m/sec and percentStandard Deviation 10.7
Secondary

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.

Time frame: 3 months

ArmMeasureGroupValue (MEAN)Dispersion
African AmericansUrinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)Urine Epinephrine0.02 ng/mg creatinineStandard Deviation 1.8
African AmericansUrinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)Urine Norepinephrine-3.7 ng/mg creatinineStandard Deviation 12.2
Non African AmericansUrinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)Urine Epinephrine-0.26 ng/mg creatinineStandard Deviation 1.4
Non African AmericansUrinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)Urine Norepinephrine-2.7 ng/mg creatinineStandard Deviation 11.1

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026