Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask

Obstructive Sleep Apnea Clinical Trial

Official title:

Bioburden and Usability Study of the Geelong Mask System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255539
• Other study ID #: MA110914
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: January 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	ResMed Ltd	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks	The population of microorganisms on mask components will be measured after 6 weeks of continuous use by a participant on their PAP therapy device to assess the safe replacement interval of the component. The impedance of the mask will also be measured to assess whether the build up of microorganisms on the mask component will affect the usability and effectiveness of the mask. Bioburden and impedance testing will be conducted in a lab environment on return of the prototype mask and components.	6 weeks
Secondary	Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask	Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the mask system. The questionnaire will include questions related to mask comfort. The participants will answer the questions using an 11-point Likert scale.	6 weeks