Obstructive Sleep Apnea
Conditions
Keywords
OSA, portable monitoring, home diagnosis
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
Interventions
DEVICEPortable monitoring
A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.
OTHERPolysomnography
One attended diagnostic sleep study.
DEVICEHome portable monitoring
Portable monitoring with WP200 device - applied by participants once at home.
DEVICELaboratory portable monitoring
Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.
Sponsors
National Cancer Institute (NCI)
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical Failure Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Prefer Home Testing Over Laboratory Testing | 1 week | The participants indicated if they preferred Home Testing or in-laboratory Testing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OSA Testing Cross-over design, single group/arm
Interventions:
One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | OSA Testing |
|---|---|
| Age, Continuous | 44 years STANDARD_DEVIATION 10.6 |
| Education less than or equal to high school | 26 participants |
| employed | 36 participants |
| Household income less than $50,000 per year | 57 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 75 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
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).
Time frame: 4 days
Population: The polysomnography area under the curve (AUC) in an ROC plot for this study was assumed to be 0.99. The AUC for home PM test was targeted at 0.88 based on published report for power of 0.90 in a population with estimated pretest probability of 75-85%, ascertained by Berlin Questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OSA Testing | Apnea Hypopnea Index (AHI) | Polysomnography AHI | 30.3 events per hour | Standard Deviation 35 |
| OSA Testing | Apnea Hypopnea Index (AHI) | Home Portable monitor AHI | 32.3 events per hour | Standard Deviation 27.6 |
| OSA Testing | Apnea Hypopnea Index (AHI) | Lab portable monitor AHI | 39.1 events per hour | Standard Deviation 29.1 |
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.
Time frame: 4 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OSA Testing | Technical Failure Rate | Home PM | 5.3 percentage of recordings |
| OSA Testing | Technical Failure Rate | Lab PM | 3.1 percentage of recordings |
Other Pre-specified
Percentage of Participants Who Prefer Home Testing Over Laboratory Testing
The participants indicated if they preferred Home Testing or in-laboratory Testing.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OSA Testing | Percentage of Participants Who Prefer Home Testing Over Laboratory Testing | 82 percentage of participants |