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The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying breathing events in participants previously diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes respiration (CSR), or obstructive sleep apnea (OSA).
Study Objectives: To compare a positive airway pressure (PAP) device's detection of respiratory events and airway status during device detected apneas with events scored on simultaneous polysomnography (PSG).
Design: Prospective PSGs of patients with sleep apnea using a new-generation PAP device.
Settings: Four clinical and academic sleep centers.
Patients: Forty-five patients with obstructive sleep apnea (OSA) and complex sleep apnea (Comp SA) performed a PSG on PAP levels adjusted to induce respiratory events.
Interventions: None.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REMstar Auto with A-Flex | Experimental | Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex. |
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| Manually Scored Polysomnography (PSG) | Other | Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be Manually Scored Polysomnography (PSG). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manipulation of Positive Airway Pressure (PAP) | Other | Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared. | During a single night of polysomnography lasting an average of 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Device Detected Apneas as Detected by Philips Respironics (PR) System One | All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway. | During a single night of polysomnography lasting an average of 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Berry, MD | University of Florida | Principal Investigator |
| Sheila Tsai, MD | National Jewish Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| University of Florida - Shands Sleep Disorders Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Apnea | Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device-Detected Obstructed Airway Apnea Agreement | Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs. | During a single night of polysomnography lasting an average of 8 hours |
| Device-Detected Clear Airway Apnea Agreement | Device Detected Clear Airways events were counted by the device. These events were then compared to manual PSG scoring. The manual PSG scoring determined that these were apnea events. However, the manual scoring allows for more channels to be reviewed and manual scoring was able to classify them into 4 different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored hypopneas and manually scored RERAs. | During a single night of polysomnography lasting an average of 8 hours |
| Gainesville |
| Florida |
| 32606 |
| United States |
| Sleep Health | Portage | Michigan | 49024 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Apnea | Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved. |
| 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/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| Diagnostic Apnea-Hypopnea Index (AHI) | Mean | Standard Deviation | events/hour |
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| Diagnosis | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography | The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared. | Posted | Mean | Standard Deviation | events/hour | During a single night of polysomnography lasting an average of 8 hours |
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| Secondary | Device Detected Apneas as Detected by Philips Respironics (PR) System One | All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway. | 1097 Device Detected Apneas were detected. | Posted | Number | events | During a single night of polysomnography lasting an average of 8 hours | Device Detected Events | Device Detected Events |
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| Secondary | Device-Detected Obstructed Airway Apnea Agreement | Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs. | 762 Device Detected Apneas were detected. | Posted | Number | events | During a single night of polysomnography lasting an average of 8 hours | Device Detected Obstructed Airway Apneas | Device Detected Obstructed Airway Apneas |
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| Secondary | Device-Detected Clear Airway Apnea Agreement | Device Detected Clear Airways events were counted by the device. These events were then compared to manual PSG scoring. The manual PSG scoring determined that these were apnea events. However, the manual scoring allows for more channels to be reviewed and manual scoring was able to classify them into 4 different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored hypopneas and manually scored RERAs. | 335 Device Detected Clear Airway Apneas were detected. | Posted | Number | events | During a single night of polysomnography lasting an average of 8 hours | Device Detected Clear Airway Apneas | Device Detected Clear Airway Apneas |
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Adverse events were collected from screening until visit 2, these two visits were up to 7 days apart.
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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 | Subjects With Sleep Apnea | Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory. | 0 | 45 | 0 | 45 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quing Yun Li, MD, PhD | Shanghai Jiao Tong University School of Medicine | 86-21-64314162 | liqingyun68@hotmail.com |
| ID | Term |
|---|---|
| D020182 | Sleep Apnea, Central |
| D002639 | Cheyne-Stokes Respiration |
| 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 |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hispanic/Latino |
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| Others |
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| Hypopnea index |
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| Respiratory effort-related arousal (RERA) index |
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| Device Detected Events |
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| Device Detected Obstructed Airway Apneas |
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| Device Detected Clear Airway Apneas |
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