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Our group has recently found that the choice of positive airway pressure mask can significantly affect the pressure required to adequately treat sleep disordered breathing. The goal of this study is to visualize the upper airway in the retropalatal and retroglossal region while using both oronasal and nasal masks with CPAP in order to investigate differences in upper airway dynamics that may occur between these two mask types.
It is known that oronasal masks are not as effective at opening the upper airway compared to nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered breathing. However, the physiological mechanism for this difference in efficacy is not known; although, it has been hypothesized to involve the retroglossal and/or retropalatal region of the upper airway. The objective of this study was to investigate differences in retroglossal and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using real-time cine magnetic resonance imaging (cMRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects-Nasal and Oronasal PAP Mask | Experimental | Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal and Oronasal PAP Mask | Device | Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AHI | The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. | through study completion, an average of 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| MRI of Upper Airway With Opposite PAP Mask | MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type. | Approximately 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Ebben, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Center for Sleep Medicine | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25924934 | Derived | Ebben MR, Milrad S, Dyke JP, Phillips CD, Krieger AC. Comparison of the upper airway dynamics of oronasal and nasal masks with positive airway pressure treatment using cine magnetic resonance imaging. Sleep Breath. 2016 Mar;20(1):79-85. doi: 10.1007/s11325-015-1187-x. Epub 2015 Apr 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects-Nasal and Oronasal PAP Mask | Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O. Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects-Nasal and Oronasal PAP Mask | Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O. Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | AHI | The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. | Posted | Mean | Standard Deviation | events per hour | through study completion, an average of 1 hour |
|
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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 | All Subjects-Nasal and Oronasal PAP Mask | Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O. Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew Ebben | Weill Cornell Medical College | 6469629318 | mae2001@med.cornell.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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|
| Secondary | MRI of Upper Airway With Opposite PAP Mask | MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type. | Posted | Count of Participants | Participants | Approximately 1 hour |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |