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

NCT01997723 | Completed Results DMC

• 2 other identifiers: 2011-0222KM1CA156717
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

OSA, portable monitoring, home diagnosis

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

  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).

  4 days

Secondary Outcomes (1)

• Technical Failure Rate

  4 days

Other Outcomes (1)

• Percentage of Participants Who Prefer Home Testing Over Laboratory Testing

  1 week

Study Arms (1)

OSA testing

EXPERIMENTAL

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

Device: Portable monitoring; Other: Polysomnography; Device: Home portable monitoring; Device: Laboratory portable monitoring

Interventions

Portable monitoring DEVICE

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

Also known as: WatchPAT200, Itamar medical Inc.

OSA testing

Polysomnography OTHER

One attended diagnostic sleep study.

OSA testing

Home portable monitoring DEVICE

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

OSA testing

Laboratory portable monitoring DEVICE

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

OSA testing

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sleep Science Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 25126034 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This trial did not compare different portable devices for diagnostic accuracy compared to polysomnography (gold standard).

Results Point of Contact

• Title: Bharati Prasad
• Organization: UIllinois

bpradsad@uic.edu

3129968433

Study Officials

• Bharati Prasad, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 28, 2013
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2013
• Last Updated: May 29, 2024
• Results First Posted: June 20, 2014

Record last verified: 2024-05

Locations

US (1)