Clinical trial NCT01960465: Race And CPAP Effectiveness
Official title: Targeted Treatment of Obstructive Sleep Apnea to Reduce Cardiovascular Disparity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Keywords: CPAP treatment
hypertension
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-10-10
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 24 Hour Ambulatory Blood Pressure
timeFrame: 3 months
Secondary outcomes:
measure: Central Aortic Blood Pressure
timeFrame: 3 months
measure: Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: Bharati Prasad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.