Obstructive Sleep Apnea (OSA)NCT00773721
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
A study testing CPAP mask in people with Obstructive Sleep Apnea (OSA), run by ResMed at 1 site in Australia.
Trial summary
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- CPAP mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 18+
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients being treated for OSA with CPAP for >6 months
- Patients using ResMed Masks
Who cannot join
- • Known to have any pre-existing dermatological condition
- Has been treated with antibiotics in the previous month
- Any condition which, in the opinion of the investigator, would make the subject unsuitable or unsafe for enrolment, or could interfere with the subject participating in and completing the protocol.
- Patients currently using ResMed masks: Swift, Activa, or Liberty.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Resmed Centre for Healthy Sleep
Sydney, New South Wales, 2153
About this study
Official title: Assessment of Bioburden in a New Mask Seal Material
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Compliance, however, to therapy requires that the mask is suitably comfortable so as not to disturb sleep.
A key contributor to comfort is the seal component of the mask system. Current mask seals are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable. It is proposed to replace the solid elastomer with a soft polymer foam.
Read more
The foam is highly porous, and has open cells at its surface. It is therefore more likely to accumulate biological material with repeated use. The current (silicone) material does not present any problematic bioburden issues. Therefore it is important to investigate whether the foam will present bioburden problems to patients, within specified usage parameters.
The aims of this study therefore are:
- to observe the rate of bacterial accumulation on foam mask seal material (polyether polyurethane,)
- to determine the replacement interval for a foam mask seal, and
- assess the comfort and function of a foam mask seal.
Read the detailed description
Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame.
Subjects will wear the test unit mask, instead of the current CPAP mask, each night whilst sleeping. Upon waking, subjects will remove the test unit mask and place it with the skin contact side uppermost on a flat surface adjacent to their bed (e.g. a bedside table). Test unit masks should not be covered, and are to remain exposed to the bedroom environment for the rest of the day. The cycle repeats for up to 35 days (5 weeks).
If necessary, the test can be terminated before this time.
A control group of 2 subjects will wash their test unit mask with only hot water every day for the 5 weeks. Another 4 subjects will have the foam of their test unit mask replaced during the 5 weeks of the trial. Two subjects will have the foam changed after 2 weeks and the other 2 subjects after 4 weeks. This will allow estimations of bioburden after 1,2,3,4 and 5 weeks of use.
The foam samples are to be sealed in the supplied sterile container. The sealed container will be delivered as soon as possible to the project administrator. The project administrator will appropriately collect, record, store, and dispatch the sealed samples for microbiological analysis.
Microbial analysis will determine the number of colony forming units, and species present in each test unit upon test termination.
Skin Reactions:
Participants will be asked to report any skin reaction they experience under the test unit. Subjects will keep a bi-weekly record of any skin redness, irritation, etc.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- CPAP mask
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP maskDevice
Current CPAP masks are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable.
Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame.
Subjects will wear the test unit mask, instead of their current CPAP mask, each night whilst sleeping.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Volunteers who are currently using CPAP treatment will trial a new mask system for up to five weeks Receives: Device: CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of bacterial accumulation in the new material.
Measured: up to 35 days (5 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Schindhelm, PhD, Principal investigator, ResMed/ The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773721
- Sponsor's protocol ID
- MA131008
- Status last verified
- Feb 2021
- First submitted
- 15 Oct 2008
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bioburden in a New Mask Seal Material
- ClinicalTrials.gov ID
- NCT00773721
- Acronym / sponsor ID
- MA131008
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. Compliance, however, to therapy requires that the mask is suitably comfortable so as not to disturb sleep.
A key contributor to comfort is the seal component of the mask system. Current mask seals are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable. It is proposed to replace the solid elastomer with a soft polymer foam.
The foam is highly porous, and has open cells at its surface. It is therefore more likely to accumulate biological material with repeated use. The current (silicone) material does not present any problematic bioburden issues. Therefore it is important to investigate whether the foam will present bioburden problems to patients, within specified usage parameters.
The aims of this study therefore are:
- to observe the rate of bacterial accumulation on foam mask seal material (polyether polyurethane,)
- to determine the replacement interval for a foam mask seal, and
- assess the comfort and function of a foam mask seal.
Detailed description
Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame.
Subjects will wear the test unit mask, instead of the current CPAP mask, each night whilst sleeping. Upon waking, subjects will remove the test unit mask and place it with the skin contact side uppermost on a flat surface adjacent to their bed (e.g. a bedside table). Test unit masks should not be covered, and are to remain exposed to the bedroom environment for the rest of the day. The cycle repeats for up to 35 days (5 weeks).
If necessary, the test can be terminated before this time.
A control group of 2 subjects will wash their test unit mask with only hot water every day for the 5 weeks. Another 4 subjects will have the foam of their test unit mask replaced during the 5 weeks of the trial. Two subjects will have the foam changed after 2 weeks and the other 2 subjects after 4 weeks. This will allow estimations of bioburden after 1,2,3,4 and 5 weeks of use.
The foam samples are to be sealed in the supplied sterile container. The sealed container will be delivered as soon as possible to the project administrator. The project administrator will appropriately collect, record, store, and dispatch the sealed samples for microbiological analysis.
Microbial analysis will determine the number of colony forming units, and species present in each test unit upon test termination.
Skin Reactions:
Participants will be asked to report any skin reaction they experience under the test unit. Subjects will keep a bi-weekly record of any skin redness, irritation, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: CPAP maskVolunteers who are currently using CPAP treatment will trial a new mask system for up to five weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are 18+
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients being treated for OSA with CPAP for >6 months
- Patients using ResMed Masks
Key exclusion criteria (4 listed)
- • Known to have any pre-existing dermatological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP maskCurrent CPAP masks are mainly silicone elastomers, which though well understood and accepted, are often uncomfortable. Test Units: The test unit is a foam seal component which directly replaces the patients existing silicone mask cushion, and is fitted to the patients existing mask frame. Subjects will wear the test unit mask, instead of their current CPAP mask, each night whilst sleeping. | Device | 1 |
Primary outcome
Measurement of bacterial accumulation in the new material.
Time frame: up to 35 days (5 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Schindhelm, PhD principal investigator
ResMed/ The University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP mask in people with Obstructive Sleep Apnea (OSA), run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of bacterial accumulation in the new material. (time frame: up to 35 days (5 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.