Obstructive Sleep Apnea, Respiratory Insufficiency
Conditions
Keywords
Obstructive sleep apnea, OSA, CPAP, CPAP mask, Non-invasive ventilation, NIV
Brief summary
This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged 2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV) treatment. The participants will undergo a monitored sleep study, followed by a 7 night trial of the Pixi mask in the home environment. During the study usability will be measured through questionnaires filled in by the parent and clinician. The study hypothesis is that the usability of the mask will be superior to the patient's usual mask.
Detailed description
This is a prospective, single group, un-blinded study sponsored by ResMed Ltd to investigate the usability of the ResMed Pediatric Nasal Mask (Pixi). Patients will be recruited from the study site's database. Parents/ guardians of patients who meet the selection criteria and voluntarily agree to participate in the study will be approached by the investigative team to obtain informed consent. Patients will attend the clinic where baseline information will be collected, including information about the patient's current therapy and data from their last PSG study. Information will be recorded on case report forms (CRF's). Data from the patient's current device will be downloaded during this visit. At this time the Pixi mask will be fitted and adjusted until it is comfortable for the child. The patient's device will be switched to a ResMed VPAP III ST-A with QuickNav if they are not already using one. The VPAP III ST-A with QuickNav will be used in the same mode (CPAP or Bi-level) as the patient's current device. The participants will undergo a monitored PSG study on the first night of the trial. They will use the Pixi mask and the VPAP III ST-A with QuickNav during this PSG. The initial therapy settings will be based on the child's usual therapy, with any therapy setting modifications made as clinically required during the PSG. Patients will then use the Pixi mask with the VPAP III ST-A with QuickNav in the home environment for 7 nights. After using the mask in the home environment, the child's legal guardian will rate their satisfaction with the Pixi mask as compared to the child's current mask. The child will also be asked to evaluate the mask if they are able.
Interventions
DEVICEPrototype mask (known as Pixi)
This is a prototype mask to be used with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) therapy. The mask attaches to the face, covering the nose, and is kept in place with headgear. Therapy is delivered through the mask via a tube which attaches to the CPAP or NIV device.
Sponsors
ResMed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Is between 2-7 years of age * Is a current PAP (Bi-level or CPAP) therapy user, defined as being on PAP therapy for at least 1 month prior to study entry * Is a current user of a nasal mask * Legal guardian can read and comprehend English * Legal guardian is willing to give written informed consent
Exclusion criteria
* Recent sinus surgery (within 6 weeks of study entry) * Concurrent participation in other clinical trials * History of clinically significant epistaxis in the past 6 months * Known co-morbidities that, per clinical judgment, would prevent compliance to therapy * Other reasons for non-compliance that affect subject's ability to use therapy such as primary claustrophobia * Significant cardiac disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask | 8 nights use | Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask. Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask | >4 hours monitored sleep study | Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. 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 patients usual mask |
Countries
Australia
Participant flow
Recruitment details
Participants were recruited from Mater Children's Hospital patient database. Patients were recruited from January - April 2011. Participants attended Mater Children's Hospital Sleep Unit to take part in the study
Participants by arm
| Arm | Count |
|---|---|
| Prototype Mask New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Prototype Mask |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.6 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment Australia | 6 participants |
| Sex: Female, Male Female | 2 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 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask
Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask. Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability.
Time frame: 8 nights use
Population: Analysis was as per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pixi Paediatric Mask Usability | Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask | 7.17 units on a scale | Standard Deviation 2.93 |
| Usual Mask | Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask | 5.83 units on a scale | Standard Deviation 1.94 |
Secondary
Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask
Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. 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 patients usual mask
Time frame: >4 hours monitored sleep study
Population: Analysis was as per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pixi Paediatric Mask Usability | Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask | 0.85 apnea hypopnoea index | Standard Deviation 0.76 |
| Usual Mask | Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask | 3.25 apnea hypopnoea index | Standard Deviation 1.57 |