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Our group previously conducted a study looking at the performance of three styles of positive airway pressure masks during laboratory treatment studies for obstructive sleep apnea, and we found that patients using a full-mask mask required higher positive airway pressures than patients using nasal or nasal pillows style masks to achieve successful reduction of respiratory events. In the current study we want to randomly assign patients to either nasal or full-face masks and then switch to a different mask (if nasal was originally chosen than the mask will be switched to full-face and vise versa) after 3-weeks of use to see if the number of respiratory events change with the different mask style. We expect the number of respiratory events will increase with the use of full-face masks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oronasal Mask | Experimental | Initial administration of oronasal CPAP mask |
|
| Nasal Mask | Experimental | Initial administration of nasal CPAP mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch CPAP mask type | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks | Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode. | 3 weeks for each mask condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Center for Sleep Medicine | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oronasal Mask | Initial administration of oronasal CPAP mask Switch CPAP mask type |
| FG001 | Nasal Mask | Initial administration of nasal CPAP mask Switch CPAP mask type |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oronasal Mask | Initial administration of oronasal CPAP mask Switch CPAP mask type |
| BG001 | Nasal Mask | Initial administration of nasal CPAP mask Switch CPAP mask type |
| 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 | Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks | Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode. | higher values represent a better outcome | Posted | Mean | Standard Deviation | minutes | 3 weeks for each mask condition |
|
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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 | Oronasal Mask | Initial administration of oronasal CPAP mask Switch CPAP mask type |
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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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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode. |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Nasal Mask | Initial administration of nasal CPAP mask Switch CPAP mask type | 0 | 7 | 0 | 7 | 0 | 7 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |