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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01312948




Registration number
NCT01312948
Ethics application status
Date submitted
6/02/2011
Date registered
11/03/2011
Date last updated
26/06/2017

Titles & IDs
Public title
Study of the Usability and Efficacy of a New Pediatric CPAP Mask
Scientific title
Pediatric Nasal Mask (Pixi) Usability Study
Secondary ID [1] 0 0
MA13122010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Respiratory Insufficiency 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Prototype mask (known as Pixi)

Experimental: Prototype mask -


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
8 nights use
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
>4 hours monitored sleep study

Eligibility
Key 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
Minimum age
2 Years
Maximum age
7 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Mater Children's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01312948
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Margaret-Anne Harris, MBBS, FRACP
Address 0 0
Lady Cilento Children's Hospital, Brisbane
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications