Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system. The mask system will be assessed according to objective data recordings and user questionnaires. It is hypothesised that the prototype mask components will not pose a health risk (with regards to bioburden and impedance) and that the mask system will pass usability objectives to adequately deliver CPAP treatment.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CPAP Nasal Mask

Geelong Prototype Mask

Group Type EXPERIMENTAL

Geelong Prototype Mask

Intervention Type DEVICE

A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial.

Interventions

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Geelong Prototype Mask

A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participants willing to give written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are over 18 years of age
* Participants who have been diagnosed with OSA
* Participants who have been established on CPAP for ≥ 6 months
* Participants currently using a ResMed nasal pillows mask

Exclusion Criteria

* Participants who are not able to provide written informed consent
* Participants who are unable to comprehend written and spoken English
* Participants who are pregnant
* Participants who are unsuitable to participate in the study in the opinion of the researcher
* Participants with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection, lung injury)
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants who are not established on a ResMed nasal pillows mask

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No