Trial Outcomes & Findings for Race And CPAP Effectiveness (NCT NCT01960465)

NCT ID: NCT01960465

Last Updated: 2020-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

220 participants

Primary outcome timeframe

3 months

Results posted on

2020-11-20

Participant Flow

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.

All participants had moderate to severe newly diagnosed/untreated OSA\> They were started on PAP therapy after visit 1.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	138	82
Overall Study COMPLETED	118	73
Overall Study NOT COMPLETED	20	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race And CPAP Effectiveness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	African Americans n=138 Participants 138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	Non African Americans n=82 Participants 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.	Total n=220 Participants Total of all reporting groups
Age, Continuous	53.74 years STANDARD_DEVIATION 10.3 • n=5 Participants	53.1 years STANDARD_DEVIATION 10.4 • n=7 Participants	53.5 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants	73 Participants n=7 Participants	194 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	138 Participants n=5 Participants	0 Participants n=7 Participants	138 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	53 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	29 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	138 participants n=5 Participants	82 participants n=7 Participants	220 participants n=5 Participants
24 hour blood pressure	130.55 mm Hg STANDARD_DEVIATION 13.9 • n=5 Participants	126.49 mm Hg STANDARD_DEVIATION 13.6 • n=7 Participants	129.02 mm Hg STANDARD_DEVIATION 13.9 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	African Americans n=118 Participants 138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	Non African Americans n=73 Participants 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.
24 Hour Ambulatory Blood Pressure Systolic BP	-1.93 mm Hg Standard Deviation 13	-0.64 mm Hg Standard Deviation 7.6
24 Hour Ambulatory Blood Pressure Diastolic BP	-1.38 mm Hg Standard Deviation 9.3	-1.19 mm Hg Standard Deviation 7.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	African Americans n=118 Participants 138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	Non African Americans n=73 Participants 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.
Central Aortic Blood Pressure Pulse Wave Velocity	-0.20 m/sec and percent Standard Deviation 2.0	-0.23 m/sec and percent Standard Deviation 1.6
Central Aortic Blood Pressure Augmentation Index	-1.20 m/sec and percent Standard Deviation 10.6	-0.68 m/sec and percent Standard Deviation 10.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	African Americans n=118 Participants 138 Self identified African American Continuous positive airway pressure: A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.	Non African Americans n=73 Participants 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.
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) Urine Epinephrine	0.02 ng/mg creatinine Standard Deviation 1.8	-0.26 ng/mg creatinine Standard Deviation 1.4
Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) Urine Norepinephrine	-3.7 ng/mg creatinine Standard Deviation 12.2	-2.7 ng/mg creatinine Standard Deviation 11.1

Adverse Events

African Americans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non African Americans

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bharati Prasad

Jesse Brown VAMC

Phone: 312-569-6343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place