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OpenTrials
Completed

NCT Number: NCT01997723

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Science Center

Chicago, Illinois, 60612, United States

About this study

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

  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female African-Americans (age ≥18 years)
  • Berlin Questionnaire
  • Ability to understand written and verbal English

Exclusion criteria

  • Past treatment of OSA (medical, dental, or surgical)
  • Other primary sleep disorder(s) by history
  • Active uncontrolled medical conditions/immobility
  • Current drug or significant alcohol use
  • No current residential address or contact phone number

Treatment and study plan

Portable monitoring

Device

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

Other names: WatchPAT200, Itamar medical Inc.

Polysomnography

Other

One attended diagnostic sleep study.

Home portable monitoring

Device

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

Laboratory portable monitoring

Device

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

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: 4 days

    AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep.

    AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG).

Secondary outcomes

  1. Technical Failure Rate

    Time frame: 4 days

    home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording.

Other outcomes

  1. Percentage of Participants Who Prefer Home Testing Over Laboratory Testing

    Time frame: 1 week

    The participants indicated if they preferred Home Testing or in-laboratory Testing.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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