Race And CPAP Effectiveness

NCT ID: NCT01960465

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2019-08-30

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.

Conditions

Sleep Apnea Syndromes

Keywords

CPAP treatment; hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

African Americans

138 Self identified African American

Group Type: EXPERIMENTAL

Continuous positive airway pressure

Intervention Type: DEVICE

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

non African Americans

53 Caucasians and 29 Other race (non African-Americans) Veterans.

Group Type: ACTIVE_COMPARATOR

Continuous positive airway pressure

Intervention Type: DEVICE

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

Interventions

Continuous positive airway pressure

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

Intervention Type: DEVICE

Other Intervention Names

CPAP

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bharati Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Jesse Brown VA Medical Center, Chicago, IL

Locations

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Countries

United States

References

Imayama I, Gallagher C, Grand J, Follman B, Kansal M, Prasad B. Defining the impact of continuous positive airway pressure therapy on diastolic function in adults with moderate-to-severe obstructive sleep apnea. J Sleep Res. 2023 Aug;32(4):e13856. doi: 10.1111/jsr.13856. Epub 2023 Feb 26.

Reference Type: DERIVED

PMID: 36843239 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34931603 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLIN-022-13S

Identifier Type: -

Identifier Source: org_study_id