Clinical trial NCT01997723: Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea
Official title: Comparative Effectiveness Research to Enhance Outcomes in African-Americans With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA, portable monitoring, home diagnosis
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-11-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 4 days
Secondary outcomes:
measure: Technical Failure Rate
timeFrame: 4 days
Other outcomes:
measure: Percentage of Participants Who Prefer Home Testing Over Laboratory Testing
timeFrame: 1 week
Locations:
city: Chicago
country: United States
facility: Sleep Science Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Bharati Prasad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.