Trial record 5 of 34 for:    continuous positive airway pressure OR CPAP | Open Studies | NIH, U.S. Fed

Race And CPAP Effectiveness (RACE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01960465
First received: September 9, 2013
Last updated: August 13, 2014
Last verified: August 2014
  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 European American Veterans.


Condition Intervention
Sleep Apnea Syndromes
Device: Continuous positive airway pressure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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 Department of Veterans Affairs:

Primary Outcome Measures:
  • 24 hour ambulatory blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Central aortic blood pressure measured noninvasively with a cuff (Sphygmocor exel).

  • Urinary sympathetic activity (catecholamines) and oxidative stress (8-isoprostane) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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
Study Start Date: May 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: African Americans
110 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: European Americans
and 110 self identified European American 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 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. We will determine the relative magnitude of hypertension response to CPAP treatment (ambulatory blood pressure and central aortic blood pressure) in 220 African American and European American Veterans with hypertension and newly diagnosed OSA (specific aim 1). We 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, we 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, we will adjust our 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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identified African American and European American Veterans
  • Age: 30-65 years
  • Hypertension
  • Apnea hypopnea index (AHI) 15/hour on diagnostic polysomnography

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960465

Contacts
Contact: Bharati Prasad, MD bharati.prasad@va.gov

Locations
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Karen M Lenehan    312-569-6343    Karen.Lenehan@va.gov   
Principal Investigator: Bharati Prasad, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Bharati Prasad, MD Jesse Brown VA Medical Center, Chicago, IL
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01960465     History of Changes
Other Study ID Numbers: CLIN-022-13S
Study First Received: September 9, 2013
Last Updated: August 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
CPAP treatment
hypertension

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014