NCT01312948

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 19, 2012

Completed
Last Updated

June 26, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

February 6, 2011

Results QC Date

October 31, 2011

Last Update Submit

May 31, 2017

Conditions

Obstructive Sleep ApneaRespiratory Insufficiency

Keywords

Obstructive sleep apneaOSACPAPCPAP maskNon-invasive ventilationNIV

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 nights use

Secondary Outcomes (1)

  • Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask

    >4 hours monitored sleep study

Study Arms (1)

Prototype mask

EXPERIMENTAL
Device: Prototype mask (known as Pixi)

Interventions

Prototype mask (known as Pixi)DEVICE

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
Prototype mask

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mater Children's Hospital

Brisbane, Queensland, 4101, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Alison Wimms
Organization
ResMed Ltd
alison.wimms@resmed.com.au
+6188842583

Study Officials

  • Margaret-Anne Harris, MBBS, FRACP

    Lady Cilento Children's Hospital, Brisbane

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2011

First Posted

March 11, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

June 26, 2017

Results First Posted

March 19, 2012

Record last verified: 2017-05

Locations

AU(1)