Obstructive Sleep ApneaNCT01312948
Study of the Usability and Efficacy of a New Pediatric CPAP Mask
A study testing Prototype mask (known as Pixi) in people with Obstructive Sleep Apnea and Respiratory Insufficiency, run by ResMed at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Obstructive Sleep Apnea, Respiratory Insufficiency
- What is being tested?
- Prototype mask (known as Pixi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2011to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Nasal Mask (Pixi) Usability Study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Respiratory Insufficiency
- Being tested
- Prototype mask (known as Pixi)
- Keywords
- Obstructive sleep apnea, OSA, CPAP, CPAP mask, Non-invasive ventilation, NIV
- Medical subject headings
- Sleep Apnea, Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype mask (known as Pixi)Device
Also called ResMed Pixi paediatric mask
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.
| Study group | Role | What they receive |
|---|---|---|
| Prototype mask | Experimental | Not described Receives: Device: Prototype mask (known as Pixi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 nights use
Secondary outcomes (1)
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
Measured: >4 hours monitored sleep study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret-Anne Harris, MBBS, FRACP, Principal investigator, Lady Cilento Children's Hospital, Brisbane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312948
- Sponsor's protocol ID
- MA13122010
- Status last verified
- May 2017
- First submitted
- 6 Feb 2011
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Nasal Mask (Pixi) Usability Study
- ClinicalTrials.gov ID
- NCT01312948
- Acronym / sponsor ID
- MA13122010
- Conditions
- Obstructive Sleep Apnea, Respiratory Insufficiency
- Keywords
- Obstructive sleep apnea, OSA, CPAP, CPAP mask, Non-invasive ventilation, NIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 19 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prototype mask | Experimental | Device: Prototype mask (known as Pixi) |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype mask (known as Pixi)Also: ResMed Pixi paediatric maskThis 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. | Device | Prototype mask |
Primary outcome
Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask
Time frame: 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.
1 secondary outcome
Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask
Time frame: >4 hours monitored sleep study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret-Anne Harris, MBBS, FRACP principal investigator
Lady Cilento Children's Hospital, Brisbane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype mask (known as Pixi) in people with Obstructive Sleep Apnea and Respiratory Insufficiency, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask (time frame: 8 nights use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.