NCT01960465: RACE

Race And CPAP Effectiveness

Completed NA Results posted Last updated 20 November 2020

What this trial tests

NA trial testing Continuous positive airway pressure in Sleep Apnea Syndromes in 220 participants. Completed in 30 August 2019.

Timeline

5 January 2015

Primary endpoint
30 August 2019

30 August 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	220
Start date	5 January 2015
Primary completion	30 August 2019
Estimated completion	30 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Continuous positive airway pressure

Conditions studied

• Sleep Apnea Syndromes — all drugs for Sleep Apnea Syndromes →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 30 to 70, any sex, with Sleep Apnea Syndromes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

24 Hour Ambulatory Blood Pressure Primary · 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.

Systolic BP

Group	Value	95% CI
African Americans	-1.93	± 13
Non African Americans	-0.64	± 7.6

Diastolic BP

Group	Value	95% CI
African Americans	-1.38	± 9.3
Non African Americans	-1.19	± 7.9

Central Aortic Blood Pressure Secondary · 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.

Pulse Wave Velocity

Group	Value	95% CI
African Americans	-0.20	± 2.0
Non African Americans	-0.23	± 1.6

Augmentation Index

Group	Value	95% CI
African Americans	-1.20	± 10.6
Non African Americans	-0.68	± 10.7

Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane) Secondary · 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.

Urine Epinephrine

Group	Value	95% CI
African Americans	0.02	± 1.8
Non African Americans	-0.26	± 1.4

Urine Norepinephrine

Group	Value	95% CI
African Americans	-3.7	± 12.2
Non African Americans	-2.7	± 11.1

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea.
   Askland K, Wright L, Wozniak DR, Emmanuel T, et al · · 2020 · cited 56× · PMID 32255210 · DOI 10.1002/14651858.cd007736.pub3
2. Socioeconomic status impacts blood pressure response to positive airway pressure treatment.
   Imayama I, Gupta A, Yen PS, Chen YF, et al · · 2022 · cited 3× · PMID 34931603 · DOI 10.5664/jcsm.9844