Obstructive Sleep ApneaNCT01847846
Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users
A study testing CPAP mask - prototype in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP mask - prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2014to Oct 2014
- 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
- At least 18 yrs old
- Diagnosed with obstructive sleep apnoea
- Been using CPAP therapy for at least 6 months
Who cannot join
- Has a lung disease/condition
- Using bilevel therapy
- Is unable to participate for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy
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.
Read more
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:
- To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks
- 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
- 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:
- The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks.
- The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks.
- 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP mask - prototype
- Keywords
- CPAP, mask, microorganisms
- 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 mask - prototypeDevice
Also called PAP mask
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.
| Study group | Role | What they receive |
|---|---|---|
| Prototype mask | Experimental | 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. Receives: Device: CPAP mask - prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks
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.
Measured: up to 8 weeks of use
Secondary outcomes (1)
Measure and compare mask efficacy over a period of 8 weeks
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
Measured: After 2, 4, 6 and 8 weeks of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847846
- Sponsor's protocol ID
- MA07052013
- Other IDs
- MA07052013
- Status last verified
- Feb 2021
- First submitted
- 30 Apr 2013
- 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
- Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy
- ClinicalTrials.gov ID
- NCT01847846
- Acronym / sponsor ID
- MA07052013
- Conditions
- Obstructive Sleep Apnea
- Keywords
- CPAP, mask, microorganisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 May 2013 (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.
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:
- To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks
- 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
- 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:
- The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks.
- The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prototype mask | Experimental | Device: CPAP mask - prototypeParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 yrs old
- Diagnosed with obstructive sleep apnoea
- Been using CPAP therapy for at least 6 months
Key exclusion criteria (3 listed)
- Has a lung disease/condition
- Using bilevel therapy
- Is unable to participate for the duration of the study
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 mask - prototypeAlso: PAP maskprototype 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. | Device | Prototype mask |
Primary outcome
To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks
Time frame: up to 8 weeks of use
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.
1 secondary outcome
Measure and compare mask efficacy over a period of 8 weeks
Time frame: After 2, 4, 6 and 8 weeks of use
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.
The record lists no contact. Use the official record to reach the sponsor.
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 - prototype in people with Obstructive Sleep Apnea, 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 3 inclusion and 3 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?
To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks (time frame: up to 8 weeks of use). 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.