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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02255539




Registration number
NCT02255539
Ethics application status
Date submitted
24/09/2014
Date registered
2/10/2014
Date last updated
1/02/2021

Titles & IDs
Public title
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
Scientific title
Bioburden and Usability Study of the Geelong Mask System
Secondary ID [1] 0 0
MA110914
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Geelong Prototype Mask

Experimental: CPAP Nasal Mask - Geelong Prototype Mask


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes from baseline in Bioburden and Impedance of the prototype mask components at 6 weeks
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
Usability ratings of the prototype mask using a visual analog scale, compared to a reference level and the participant's current mask
Timepoint [1] 0 0
6 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Supportive Care
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2153 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02255539
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus Schindhelm, BE PhD
Address 0 0
Graduate School of Biomedical Engineering, University of New South Wales, Sydney Australia and Applied Research, ResMed Ltd Sydney Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02255539