Trial Outcomes & Findings for Study of the Usability and Efficacy of a New Pediatric CPAP Mask (NCT NCT01312948)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

8 nights use

Results posted on

2017-06-26

Participant Flow

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

Participant milestones

Participant milestones
Measure	Prototype Mask New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prototype Mask n=6 Participants New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	4.6 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment Australia	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 nights use

Population: Analysis was as per protocol

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.

Outcome measures

Outcome measures
Measure	Pixi Paediatric Mask Usability n=6 Participants Usability (overall performance) score of the Pixi paediatric mask	Usual Mask n=6 Participants Usability (overall performance) score of the child's usual CPAP mask
Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask	7.17 units on a scale Standard Deviation 2.93	5.83 units on a scale Standard Deviation 1.94

SECONDARY outcome

Timeframe: >4 hours monitored sleep study

Population: Analysis was as per protocol

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

Outcome measures

Outcome measures
Measure	Pixi Paediatric Mask Usability n=6 Participants Usability (overall performance) score of the Pixi paediatric mask	Usual Mask n=6 Participants Usability (overall performance) score of the child's usual CPAP mask
Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask	0.85 apnea hypopnoea index Standard Deviation 0.76	3.25 apnea hypopnoea index Standard Deviation 1.57

Adverse Events

Prototype Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alison Wimms

ResMed Ltd

Phone: +6188842583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place