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Race And CPAP Effectiveness (RACE)

This study is currently recruiting participants.
Verified September 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960465
First Posted: October 10, 2013
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Sleep Apnea Syndromes Device: Continuous positive airway pressure

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 24 hour ambulatory blood pressure [ Time Frame: 3 months ]
    Mean systolic and diastolic blood pressure measured over 24 hours with ambulatory monitor (Spacelabs).


Secondary Outcome Measures:
  • Central aortic blood pressure [ Time Frame: 3 months ]
    Central aortic blood pressure measured noninvasively with a cuff (SphygmoCor XCEL)

  • Urinary sympathetic activity (catecholamines) and oxidative stress (8-isoprostane) [ Time Frame: 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.


Estimated Enrollment: 220
Actual Study Start Date: January 5, 2015
Estimated Study Completion Date: December 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: African Americans
160 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 Name: CPAP
Active Comparator: non African Americans
and 60 Other race (non African Americans) Veterans will be enrolled.
Device: Continuous positive airway pressure
A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
Other Name: CPAP

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960465


Contacts
Contact: Bharati Prasad, MD bharati.prasad@va.gov
Contact: Israel Rubinstein, MD (312) 569-6129 Israel.Rubinstein@va.gov

Locations
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL Recruiting
Chicago, Illinois, United States, 60612
Contact: Karen M Lenehan    312-569-6343    Karen.Lenehan@va.gov   
Contact: Israel Rubinstein, MD    (312) 569-6129    Israel.Rubinstein@va.gov   
Principal Investigator: Bharati Prasad, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Bharati Prasad, MD Jesse Brown VA Medical Center, Chicago, IL
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01960465     History of Changes
Other Study ID Numbers: CLIN-022-13S
First Submitted: September 9, 2013
First Posted: October 10, 2013
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases