RACE: Race And CPAP Effectiveness

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01960465
• Collaborator: (none)
• Enrollment: 220
• Location: 1
• Arms: 2
• Actual Duration (Months): 55.8
• Patients Per Site Per Month: 3.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes	Device: Continuous positive airway pressure	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 220 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Targeted Treatment of Obstructive Sleep Apnea to Reduce Cardiovascular Disparity
• Actual Study Start Date: Jan 5, 2015
• Actual Primary Completion Date: Aug 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: African Americans 138 Self identified African American	Device: Continuous positive airway pressure; A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.; Other Names: CPAP
Active Comparator: non African Americans 53 Caucasians and 29 Other race (non African-Americans) Veterans.	Device: Continuous positive airway pressure; A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.; Other Names: CPAP

Outcome Measures

Primary Outcome Measures

1. 24 Hour Ambulatory Blood Pressure [3 months]

   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

1. Central Aortic Blood Pressure [3 months]

   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.

2. Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) [3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Bharati Prasad, MD, Jesse Brown VA Medical Center, Chicago, IL

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 8, 2019

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01960465
• Other Study ID Numbers: CLIN-022-13S
• First Posted: Oct 10, 2013
• Last Update Posted: Nov 20, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by VA Office of Research and Development: CPAP treatment; hypertension
• Additional relevant MeSH terms: Sleep Apnea Syndromes

Study Results

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

Arm/Group Title	African Americans	Non African Americans
Arm/Group Description	138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	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.
Period Title: Overall Study
STARTED	138	82
COMPLETED	118	73
NOT COMPLETED	20	9

Baseline Characteristics

Arm/Group Title	African Americans	Non African Americans	Total
Arm/Group Description	138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	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.	Total of all reporting groups
Overall Participants	138	82	220
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.74 (10.3)	53.1 (10.4)	53.5 (10.3)
Sex: Female, Male (Count of Participants)
Female	17 12.3%	9 11%	26 11.8%
Male	121 87.7%	73 89%	194 88.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	138 100%	0 0%	138 62.7%
White	0 0%	53 64.6%	53 24.1%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	29 35.4%	29 13.2%
Region of Enrollment (participants) [Number]
United States	138 100%	82 100%	220 100%
24 hour blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	130.55 (13.9)	126.49 (13.6)	129.02 (13.9)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African Americans	Non African Americans
Arm/Group Description	138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	82 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.
Measure Participants	118	73
Systolic BP	-1.93 (13)	-0.64 (7.6)
Diastolic BP	-1.38 (9.3)	-1.19 (7.9)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African Americans	Non African Americans
Arm/Group Description	138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	82 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.
Measure Participants	118	73
Pulse Wave Velocity	-0.20 (2.0)	-0.23 (1.6)
Augmentation Index	-1.20 (10.6)	-0.68 (10.7)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	African Americans	Non African Americans
Arm/Group Description	138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	82 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.
Measure Participants	118	73
Urine Epinephrine	0.02 (1.8)	-0.26 (1.4)
Urine Norepinephrine	-3.7 (12.2)	-2.7 (11.1)

Adverse Events

Time Frame	3-5months.
Adverse Event Reporting Description	AE and SAE definitions used were consistent with clinicaltrials.gov.
Arm/Group Title	African Americans		Non African Americans
Arm/Group Description	138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.		82 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.
All Cause Mortality
	African Americans		Non African Americans
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/82 (0%)
Serious Adverse Events
	African Americans		Non African Americans
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/82 (0%)
Other (Not Including Serious) Adverse Events
	African Americans		Non African Americans
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/138 (0%)		0/82 (0%)

Limitations/Caveats

The limitations of the study are as follows: Lower than anticipated enrollment of Whites & lower than anticipated adherence to CPAP therapy overall, particularly in African American Veterans.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.