Obstructive Sleep Apnea (OSA)GVFECTNCT02805777
Vent Flow Study of Prototype Nasal CPAP Mask
A study testing CPAP mask in people with Obstructive Sleep Apnea (OSA), run by ResMed.
Trial summary
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to Dec 2017
- 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
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants using APAP for >6 months
- Participants who are willing to use the mask system for the 3 month duration of the trial.
- Participants who are over 18 years of age
- Participants who currently use a nasal mask system
Who cannot join
- Participants not willing to give written informed consent
- Participants who cannot read and comprehend English
- Participants using an inappropriate mask system
- Participants on a Bilevel or ASV therapy
- Participants who are pregnant
- Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer lung injury; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection
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- Participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (Non-ferrous implants may be acceptable)
- Participants that weight <30 kg
- Participants who are unsuitable to participate in the study in the opinion of the researcher
About this study
Official title: Long Term Vent Flow Study of Prototype Nasal CPAP Mask System
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.
- 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
A new vent CPAP mask system will be used in this trial
| Study group | Role | What they receive |
|---|---|---|
| Washing procedure 1 | Experimental | this group will apply washing technique 1 Receives: Device: CPAP mask |
| 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.
Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial.
The mask system will be flow tested after use when returned by the participant at each scheduled visit. The flow of the mask system will be recorded as per the mask to flow procedure of ISO17510 Sleep apnoea breathing therapy - Part 2: Annex B Exhaust flow test procedure.
The results will be reported as an average flow in LPM. Results will be presented graphically with average flow on the vertical axis and use time (weeks) on the horizontal axis. This will allow us to assess any changes in vent flow over time.
Measured: 12 weeks
Secondary outcomes (3)
Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed
Measured: 12 weeks
Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.
This data will be collected from questionnaires completed in the home environment during use of the mask. The outcome will be descriptive in nature. When there is a single rating which expresses how good the product is, we will set a criterion value C which will be regarded as acceptable. The statistical test used will be the Wilcoxon signed ranks method.
Measured: 12 weeks
Bioburden quantification by laboratory testing of venting components at end of trial
The viable microorganisms present on the mask system upon completion of the trial will be counted using ISO 11737 Sterilisation of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products.
Results will be presented as total quantity of Microorganism (log10 CFU) per diffuser.
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 posted20 Jun 2016 (estimated)
- Study start1 May 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Study not required due to change in device
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.
- 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
- 0 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
- NCT02805777
- Sponsor's protocol ID
- MA300516
- Acronym
- GVFECT
- Status last verified
- Feb 2021
- First submitted
- 1 Jun 2016
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no sharing plan.
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
- Long Term Vent Flow Study of Prototype Nasal CPAP Mask System
- ClinicalTrials.gov ID
- NCT02805777
- Acronym / sponsor ID
- GVFECT / MA300516
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not required due to change in device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 1 May 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jun 2016 (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 choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washing procedure 1 | Experimental | Device: CPAP maskthis group will apply washing technique 1 |
| 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)
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants using APAP for >6 months
- Participants who are willing to use the mask system for the 3 month duration of the trial.
- Participants who are over 18 years of age
Key exclusion criteria (9 listed)
- Participants not willing to give written informed consent
- Participants who cannot read and comprehend English
- Participants using an inappropriate mask system
- Participants on a Bilevel or ASV therapy
- Participants who are pregnant
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 | Washing procedure 1, Washing procedure 2 |
Primary outcome
Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial.
Time frame: 12 weeks
The mask system will be flow tested after use when returned by the participant at each scheduled visit. The flow of the mask system will be recorded as per the mask to flow procedure of ISO17510 Sleep apnoea breathing therapy - Part 2: Annex B Exhaust flow test procedure. The results will be reported as an average flow in LPM. Results will be presented graphically with average flow on the vertical axis and use time (weeks) on the horizontal axis. This will allow us to assess any changes in vent flow over time.
3 secondary outcomes
Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed
Time frame: 12 weeks
Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.
Time frame: 12 weeks
Bioburden quantification by laboratory testing of venting components at end of trial
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No. There is no sharing plan.
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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
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.
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 9 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial. (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 4 Feb 2021.