Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
Detailed description
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.
Interventions
DEVICEPixi 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.
Sponsors
ResMed
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* 2-7 years of age * Diagnosis of OSA * Current PAP therapy user * Current nasal mask user
Exclusion criteria
* Recent sinus surgery * Allergies to mask material * Current seasonal allergies that could interfere with therapy * History of clinically significant epistaxis in past 6 months * Upper airway surgery less than 60 days before study entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | Baseline AHI | 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. |
| Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | AHI after min 21 days use with Pixi 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Pediatric Mask |
|---|---|
| Age, Categorical <=18 years | 16 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
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.
Time frame: Baseline AHI
Population: Subjects who completed all visits and procedures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Currently-used Mask | Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | 2.7 AHI (events/hour) | Standard Deviation 5.6 |
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.
Time frame: AHI after min 21 days use with Pixi mask
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Currently-used Mask | Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask | 1.2 AHI (events/hour) | Standard Deviation 1.5 |