An interventional study of Prototype mask (known as Pixi) in Obstructive Sleep Apnea and Respiratory Insufficiency, sponsored by ResMed. Completed at 1 site in Australia. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2017-06-26.
Sponsored by ResMed · Not applicable, Interventional, and Treatment
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.
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 6 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Prototype 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.
Also known as: ResMed Pixi paediatric mask
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
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
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
| Milestone | Prototype Mask |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| units on a scale | Pixi Paediatric Mask Usability | Usual Mask |
|---|---|---|
| Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask | 7.17 ± 2.93 | 5.83 ± 1.94 |
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
| apnea hypopnoea index | Pixi Paediatric Mask | Usual Mask |
|---|---|---|
| Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask | 0.85 ± 0.76 | 3.25 ± 1.57 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prototype Mask | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Prototype Mask |
|---|---|
| <=18 years | 6 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Prototype Mask |
|---|---|
| Mean | 4.6 ± 1.8 |
| Sex: Female, Male(Participants) | Prototype Mask |
|---|---|
| Female | 2 |
| Male | 4 |
| Region of Enrollment(participants) | Prototype Mask |
|---|---|
| Australia | 6 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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