Race And CPAP Effectiveness

NCT01960465 | Completed Results DMC FDA Device

• 1 other identifier: CLIN-022-13S
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

CPAP treatment; hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Central Aortic Blood Pressure

  3 months

• Urinary Sympathetic Activity (Catecholamines) and Oxidative Stress (8-isoprostane)

  3 months

Study Arms (2)

African Americans

EXPERIMENTAL

138 Self identified African American

Device: Continuous positive airway pressure

non African Americans

ACTIVE COMPARATOR

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

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressure DEVICE

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

Also known as: CPAP

African Americans; non African Americans

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 36843239 DERIVED

• 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.

  PMID: 34931603 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Bharati Prasad
• Organization: Jesse Brown VAMC

bharati.prasad@va.gov

312-569-6343

Study Officials

• Bharati Prasad, MD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: October 10, 2013
• Study Start: January 5, 2015
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)