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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01847846
Registration number
NCT01847846
Ethics application status
Date submitted
30/04/2013
Date registered
7/05/2013
Date last updated
4/02/2021
Titles & IDs
Public title
Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users
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Scientific title
Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy
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Secondary ID [1]
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MA07052013
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Secondary ID [2]
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MA07052013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - CPAP mask - prototype
Experimental: Prototype mask - Participants will be randomised to trial the new prototype mask for 4 and 8 weeks. The prototype mask will be used in conjunction with the participant's home CPAP machine. The participant's will be instructed to use the prototype mask every night until the completion of the trial. No changes will be made to the participant's prescribed CPAP settings.
Treatment: Devices: CPAP mask - prototype
prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks
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Assessment method [1]
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The mask is for single user use only. The participants will be instructed not to wash or clean the material for the duration of the study. The mask will be returned in a sealed bag and sent off for testing within 24 hrs after the trial.
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Timepoint [1]
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up to 8 weeks of use
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Secondary outcome [1]
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Measure and compare mask efficacy over a period of 8 weeks
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Assessment method [1]
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The efficacy variables that will be measured and compared at each time point are:
Apnea Hypopnea Index (AHI; the number of apneas and hypopneas per hour), mask leak, number of hours of use per night, and user compliance will be measured
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Timepoint [1]
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After 2, 4, 6 and 8 weeks of use
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Eligibility
Key inclusion criteria
* At least 18 yrs old
* Diagnosed with obstructive sleep apnoea
* Been using CPAP therapy for at least 6 months
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has a lung disease/condition
* Using bilevel therapy
* Is unable to participate for the duration of the study
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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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ResMed Ltd - Bella Vista
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Recruitment postcode(s) [1]
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2153 - Bella Vista
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ResMed
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask. The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time. ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy. AIMS The aims of the study are: 1. To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks 2. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks 3. To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask It is hypothesised that: 1. The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks. 2. The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks. 3. Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.
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Trial website
https://clinicaltrials.gov/study/NCT01847846
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Fax
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01847846
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