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The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
Obstructive sleep apnea (OSA) is a condition in which there is partial or complete collapse of the upper airway during sleep. Features of OSA include snoring to upper airway resistance, which could be mild to severe. While OSA has been studied extensively in an adult population, research indicates that OSA is prevalent in a pediatric population as well, though the options for treatment are not as varied as that for the adult population. The study seeks to determine if a mask made for a pediatric population effectively treats their OSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric mask | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pixi pediatric mask | Device | The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask. | Baseline AHI |
| Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask. | AHI after min 21 days use with Pixi mask |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Center for Human Sleep Research | Redwood City | California | 94063 | United States | ||
| The Children's Hopsital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Mask | Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Mask | Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study. |
| 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 | Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask. | Subjects who completed all visits and procedures | Posted | Mean | Standard Deviation | AHI (events/hour) | Baseline AHI |
|
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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 | Overall Study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Seizure unrelated to use of PAP/Pixi mask |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| June Mendoza | ResMed | 1-800-424-0737 | june.mendoza@resmed.com |
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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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|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Gaylord Sleep Medicine | Wallingford | Connecticut | 06492 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask. | Posted | Mean | Standard Deviation | AHI (events/hour) | AHI after min 21 days use with Pixi mask |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |