Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea

NCT ID: NCT01997723

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-04-30

Brief Summary

Obstructive Sleep Apnea (OSA) is under-diagnosed and is associated with increased cardiovascular morbidity and mortality. Laboratory-based overnight polysomnography (PSG) is the gold standard in clinical practice to diagnose OSA but has availability, cost, and resource limitations. In the last decade, an alternative diagnostic strategy, Portable Monitoring (PM) has emerged with the goal of reducing expense and delays in clinical management. In contrast to PSG, PM maybe performed unattended in homes, utilize different neurophysiologic and cardiorespiratory parameters, and may synthesize these data differently. PM is feasible and is approved by Centers for Medicare and Medicaid Services (CMS) in the United States. However, the diagnostic utility of PM in minority and underserved populations is not defined.

African-Americans are more severely affected by hypertension and cardiovascular disease (CVD) than other ethnic groups and OSA is more common in this population. OSA is a treatable cause of hypertension. Despite this the impact of timely interventions for OSA on health outcomes and risk reduction specific to African Americans is unknown.

Purpose of this research: In view of the vulnerability of this population and the potential for improvement in healthcare access for OSA with home-based diagnosis, this study aims to establish the feasibility and identify the potential advantages and limitations of home-based diagnosis of OSA in a high-risk urban African-American population including veterans with frequently limited access to healthcare.

Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard laboratory-based PSG in effectively diagnosing OSA in urban African Americans.

Detailed Description

Hypothesis: The investigators hypothesize that home-based PM is not inferior to standard laboratory-based PSG in effectively diagnosing OSA in urban African Americans.

The specific aims of this project are:

Primary Aims: Aim 1. To compare the validity of a comprehensive and current PM technology to standard in-laboratory full PSG

1a) to measure and compare diagnostic accuracy of home-based PM with laboratory-PSG

1. b) to measure and compare diagnostic accuracy of simultaneous laboratory-based PM with laboratory-PSG Aim 2. To test the reliability and examine the applicability of PM in the home-setting

2. a) to compare diagnostic accuracy of home-based PM with laboratory-based PM

2b) to examine factors associated with technical reliability (data failure rate) of home-based PM 2c) to compare patient satisfaction and preference of testing in home-setting to laboratory-setting

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

OSA testing

Cross-over design, single group/arm Interventions: polysomnography with simultaneous portable monitoring and home portable monitoring administered to each participant in random order.

Group Type: EXPERIMENTAL

Portable monitoring

Intervention Type: DEVICE

A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.

Polysomnography

Intervention Type: OTHER

One attended diagnostic sleep study.

Home portable monitoring

Intervention Type: DEVICE

Portable monitoring with WP200 device - applied by participants once at home.

Laboratory portable monitoring

Intervention Type: DEVICE

Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.

Interventions

Portable monitoring

A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.

Intervention Type: DEVICE

Polysomnography

One attended diagnostic sleep study.

Intervention Type: OTHER

Home portable monitoring

Portable monitoring with WP200 device - applied by participants once at home.

Intervention Type: DEVICE

Laboratory portable monitoring

Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.

Intervention Type: DEVICE

Other Intervention Names

WatchPAT200, Itamar medical Inc.

Eligibility Criteria

Inclusion Criteria

1. Male and Female African-Americans (age ≥18 years)

2. Berlin Questionnaire

3. Ability to understand written and verbal English

Exclusion Criteria

1. Past treatment of OSA (medical, dental, or surgical)

2. Other primary sleep disorder(s) by history

3. Active uncontrolled medical conditions/immobility

4. Current drug or significant alcohol use

5. No current residential address or contact phone number

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Bharati Prasad

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bharati Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Sleep Science Center

Chicago, Illinois, United States

Countries

United States

References

Garg N, Rolle AJ, Lee TA, Prasad B. Home-based diagnosis of obstructive sleep apnea in an urban population. J Clin Sleep Med. 2014 Aug 15;10(8):879-85. doi: 10.5664/jcsm.3960.

Reference Type: DERIVED

PMID: 25126034 (View on PubMed)

Other Identifiers

KM1CA156717

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011-0222

Identifier Type: -

Identifier Source: org_study_id