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Trial details imported from ClinicalTrials.gov

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

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
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
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
Sex
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
Not applicable
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
1/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
6
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01312948