Sleep Apnea Syndromes
Conditions
Keywords
CPAP treatment, hypertension
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.
Interventions
A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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 details
All participants had moderate to severe newly diagnosed/untreated OSA\> They were started on PAP therapy after visit 1.
Participants by arm
| Arm | Count |
|---|---|
| African Americans 138 Self identified African American
Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea. | 138 |
| Non African Americans 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. | 82 |
| Total | 220 |
Baseline characteristics
| Characteristic | Total | Non African Americans | African Americans |
|---|---|---|---|
| 24 hour blood pressure | 129.02 mm Hg STANDARD_DEVIATION 13.9 | 126.49 mm Hg STANDARD_DEVIATION 13.6 | 130.55 mm Hg STANDARD_DEVIATION 13.9 |
| Age, Continuous | 53.5 years STANDARD_DEVIATION 10.3 | 53.1 years STANDARD_DEVIATION 10.4 | 53.74 years STANDARD_DEVIATION 10.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 138 Participants | 0 Participants | 138 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 29 Participants | 29 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 53 Participants | 0 Participants |
| Region of Enrollment United States | 220 participants | 82 participants | 138 participants |
| Sex: Female, Male Female | 26 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 194 Participants | 73 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 0 / 82 |
| other Total, other adverse events | 0 / 138 | 0 / 82 |
| serious Total, serious adverse events | 0 / 138 | 0 / 82 |
Outcome results
24 Hour Ambulatory Blood Pressure
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| African Americans | 24 Hour Ambulatory Blood Pressure | Systolic BP | -1.93 mm Hg | Standard Deviation 13 |
| African Americans | 24 Hour Ambulatory Blood Pressure | Diastolic BP | -1.38 mm Hg | Standard Deviation 9.3 |
| Non African Americans | 24 Hour Ambulatory Blood Pressure | Systolic BP | -0.64 mm Hg | Standard Deviation 7.6 |
| Non African Americans | 24 Hour Ambulatory Blood Pressure | Diastolic BP | -1.19 mm Hg | Standard Deviation 7.9 |
Central Aortic Blood Pressure
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| African Americans | Central Aortic Blood Pressure | Pulse Wave Velocity | -0.20 m/sec and percent | Standard Deviation 2 |
| African Americans | Central Aortic Blood Pressure | Augmentation Index | -1.20 m/sec and percent | Standard Deviation 10.6 |
| Non African Americans | Central Aortic Blood Pressure | Pulse Wave Velocity | -0.23 m/sec and percent | Standard Deviation 1.6 |
| Non African Americans | Central Aortic Blood Pressure | Augmentation Index | -0.68 m/sec and percent | Standard Deviation 10.7 |
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| African Americans | Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) | Urine Epinephrine | 0.02 ng/mg creatinine | Standard Deviation 1.8 |
| African Americans | Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) | Urine Norepinephrine | -3.7 ng/mg creatinine | Standard Deviation 12.2 |
| Non African Americans | Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) | Urine Epinephrine | -0.26 ng/mg creatinine | Standard Deviation 1.4 |
| Non African Americans | Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) | Urine Norepinephrine | -2.7 ng/mg creatinine | Standard Deviation 11.1 |