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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African Americans | Experimental | 138 Self identified African American |
|
| non African Americans | Active Comparator | 53 Caucasians and 29 Other race (non African-Americans) Veterans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | A portable ventilatory assist device, which is the standard first line treatment of sleep apnea. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bharati Prasad, MD | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36843239 | Derived | 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. | |
| 34931603 | Derived |
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All participants had moderate to severe newly diagnosed/untreated OSA> They were started on PAP therapy after visit 1.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population consisted of 191 participants, after accounting for drop-out and missing data for primary outcome of 24-hour BP.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non African Americans |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | 3 months |
|
3-5months.
AE and SAE definitions used were consistent with clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The limitations of the study are as follows: Lower than anticipated enrollment of Whites & lower than anticipated adherence to CPAP therapy overall, particularly in African American Veterans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bharati Prasad | Jesse Brown VAMC | 312-569-6343 | bharati.prasad@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2019 | Sep 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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|
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. |
| 3 months |
| 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. |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 24 hour blood pressure | Mean | Standard Deviation | mm Hg |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | m/sec and percent | 3 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mg creatinine | 3 months |
|
|
|
| 0 |
| 138 |
| 0 |
| 138 |
| 0 |
| 138 |
| EG001 | Non African Americans | 82 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. | 0 | 82 | 0 | 82 | 0 | 82 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012138 |
| Respiratory Therapy |