Study of the Usability and Efficacy of a New Pediatric CPAP Mask

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ResMed

ClinicalTrials.gov Identifier:

NCT01312948

First received: February 6, 2011

Last updated: April 9, 2012

Last verified: August 2011

History of Changes

Results First Received: October 31, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Obstructive Sleep Apnea Respiratory Insufficiency
Intervention:	Device: Prototype mask (known as Pixi)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from Mater Children's Hospital patient database. Patients were recruited from January - April 2011. Participants attended Mater Children's Hospital Sleep Unit to take part in the study

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Prototype Mask	New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy

Participant Flow: Overall Study

	Prototype Mask
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Prototype Mask	New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy

Baseline Measures

	Prototype Mask
Number of Participants [units: participants]	6
Age [units: participants]
<=18 years	6
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	4.6 ± 1.8
Gender [units: participants]
Female	2
Male	4
Region of Enrollment [units: participants]
Australia	6

Outcome Measures

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1. Primary:

Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask [ Time Frame: 8 nights use ]

Measure Type	Primary
Measure Title	Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask
Measure Description	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.
Time Frame	8 nights use
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was as per protocol

Reporting Groups

	Description
Pixi Paediatric Mask Usability	Usability (overall performance) score of the Pixi paediatric mask
Usual Mask	Usability (overall performance) score of the child's usual CPAP mask

Measured Values

	Pixi Paediatric Mask Usability	Usual Mask
Number of Participants Analyzed [units: participants]	6	6
Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask [units: units on a scale] Mean ± Standard Deviation	7.17 ± 2.93	5.83 ± 1.94

No statistical analysis provided for Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask

2. Secondary:

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 ]

Measure Type	Secondary
Measure Title	Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask
Measure Description	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
Time Frame	>4 hours monitored sleep study
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was as per protocol

Reporting Groups

	Description
Pixi Paediatric Mask	Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
Usual Mask	Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy

Measured Values

	Pixi Paediatric Mask	Usual Mask
Number of Participants Analyzed [units: participants]	6	6
Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask [units: apnea hypopnoea index] Mean ± Standard Deviation	0.85 ± 0.76	3.25 ± 1.57

No statistical analysis provided for Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Alison Wimms
Organization: ResMed Ltd
phone: +6188842583
e-mail: alison.wimms@resmed.com.au

No publications provided

Responsible Party:	ResMed
ClinicalTrials.gov Identifier:	NCT01312948 History of Changes
Other Study ID Numbers:	MA13122010
Study First Received:	February 6, 2011
Results First Received:	October 31, 2011
Last Updated:	April 9, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

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