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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997723
• Other study ID #: 2011-0222
• Secondary ID: KM1CA156717
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2013

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Other:
• Polysomnography
One attended diagnostic sleep study.

Device:
• Home portable monitoring
Portable monitoring with WP200 device - applied by participants once at home.
• Laboratory portable monitoring
Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.

Locations

Country	Name	City	State
United States	Sleep Science Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Who Prefer Home Testing Over Laboratory Testing	The participants indicated if they preferred Home Testing or in-laboratory Testing.	1 week
Primary	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	Technical Failure Rate	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.	4 days