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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
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Scientific title
Pediatric Nasal Mask (Pixi) Usability Study
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Secondary ID [1]
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MA13122010
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Respiratory Insufficiency
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask
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Assessment method [1]
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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.
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Timepoint [1]
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8 nights use
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Secondary outcome [1]
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Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask
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Assessment method [1]
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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
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Timepoint [1]
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>4 hours monitored sleep study
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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
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Minimum age
2
Years
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Maximum age
7
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Mater Children's Hospital - Brisbane
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Recruitment postcode(s) [1]
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4101 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ResMed
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01312948
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Margaret-Anne Harris, MBBS, FRACP
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Address
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Lady Cilento Children's Hospital, Brisbane
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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
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