Obstructive Sleep Apnoea (OSA)NCT01575210
Assessment of the Performance of a New Reduced Noise Mask Vent
A study testing CPAP mask in people with Obstructive Sleep Apnoea (OSA), run by ResMed at 1 site in Australia.
Trial summary
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnoea (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
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2012to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are using ResMed mask
- Subjects willing to provide written informed consent
- Subjects who have been treated for OSA > 6 months
- Subjects who can read and comprehend English
- Subjects ≥ 18 years old
- Subjects who are using a ResMed S8 or S9 device
Who cannot join
- Patients who are pregnant
- Patient on bi level treatment
- Patients being treated for OSA < 6 months
- Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (<2 years ago) case of pneumonia or lung infection; lung injury).
- Patients who are deemed unsuitable by the researcher due to the following reasons:
- They do not comprehend English
- They are unable to provide written informed consent
- They are physically unable to comply with the protocol
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: Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.
- Conditions
- Obstructive Sleep Apnoea (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
A new vent CPAP mask system will be used in this trial.
CPAP maskDevice
A new vent CPAP mask system will be used in this trial
| Study group | Role | What they receive |
|---|---|---|
| Group A_ washing procedure 1 | Experimental | This group will apply washing technique 1. Receives: Device: CPAP mask |
| Group B_washing procedure 2 | Experimental | This group will apply washing technique 2. Receives: Device: CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
Breathing disruption events per hour of sleep will be measured and analysed
Measured: 12 weeks
Secondary outcomes (2)
The level of comfort patients experience while using the new mask vent
Patients will complete a questionnaire regarding the noise of the new vent
Measured: 12 weeks
Patient's and bed partner's perceptions of the mask vent
Patients partners will complete a questionnaire regarding the noise of the mask vent
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnoea (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT01575210
- Sponsor's protocol ID
- MA210212
- Status last verified
- Feb 2021
- First submitted
- 27 Mar 2012
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
- ClinicalTrials.gov ID
- NCT01575210
- Acronym / sponsor ID
- MA210212
- Conditions
- Obstructive Sleep Apnoea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Apr 2012 (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.
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A_ washing procedure 1 | Experimental | Device: CPAP maskThis group will apply washing technique 1. |
| Group B_washing procedure 2 | Experimental | Device: CPAP maskThis group will apply washing technique 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who are using ResMed mask
- Subjects willing to provide written informed consent
- Subjects who have been treated for OSA > 6 months
- Subjects who can read and comprehend English
- Subjects ≥ 18 years old
Key exclusion criteria (8 listed)
- Patients who are pregnant
- Patient on bi level treatment
- Patients being treated for OSA < 6 months
- Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (<2 years ago) case of pneumonia or lung infection; lung injury).
- Patients who are deemed unsuitable by the researcher due to the following reasons:
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 maskA new vent CPAP mask system will be used in this trial. | Device | Group A_ washing procedure 1 |
| CPAP maskA new vent CPAP mask system will be used in this trial | Device | Group B_washing procedure 2 |
Primary outcome
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
Time frame: 12 weeks
Breathing disruption events per hour of sleep will be measured and analysed
2 secondary outcomes
The level of comfort patients experience while using the new mask vent
Time frame: 12 weeks
Patient's and bed partner's perceptions of the mask vent
Time frame: 12 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 1 Mar 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 Apnoea (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 6 inclusion and 8 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 1 Mar 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?
The apnoea/hypopnoea index (AHI) will be recorded and analysed. (time frame: 12 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 1 Mar 2021.