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| ID | Type | Description | Link |
|---|---|---|---|
| KM1CA156717 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable monitoring | Device | A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Prefer Home Testing Over Laboratory Testing | The participants indicated if they preferred Home Testing or in-laboratory Testing. | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bharati Prasad, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Science Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25126034 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Cross-over design, single group/arm Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Polysomnography | Other | One attended diagnostic sleep study. |
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| Home portable monitoring | Device | Portable monitoring with WP200 device - applied by participants once at home. |
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| Laboratory portable monitoring | Device | Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography. |
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| COMPLETED |
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| NOT COMPLETED |
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Consenting adult men and women of self-identified African American ethnicity meeting inclusion/exclusion criteria were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | OSA Testing | Cross-over design, single group/arm Interventions: One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| employed | 36/75 were employed, 39/75 were umemployed. | Number | participants |
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| Household income less than $50,000 per year | 57/75 had household income < $50,000 per annum and 18 had household income >/= $50,000 per annum | Number | participants |
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| Education less than or equal to high school | 26/75 had \ | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | events per hour | 4 days |
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| 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. | Posted | Number | percentage of recordings | 4 days |
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| 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. | Posted | Number | percentage of participants | 1 week |
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2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OSA Testing | Cross-over design, single group/arm Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA. | 0 | 75 | 0 | 75 |
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This trial did not compare different portable devices for diagnostic accuracy compared to polysomnography (gold standard).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bharati Prasad | UIllinois | 3129968433 | bpradsad@uic.edu |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Home PM |
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| Lab PM |
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| Title | Denominators | Categories |
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