Study of the Usability and Efficacy of a New Pediatric CPAP Mask

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pediatric Nasal Mask (Pixi) Usability Study

Conditions
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Obstructive Sleep Apnea, Respiratory Insufficiency

Intervention / Treatment
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* Device: Prototype mask (known as Pixi)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prototype mask<br> | Device: Prototype mask (known as Pixi)<br>* 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.<br>* Other names: ResMed Pixi paediatric mask;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 nights use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | >4 hours monitored sleep study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, Obstructive sleep apnea, CPAP, CPAP mask, Non-invasive ventilation, NIV