Obstructive Sleep ApneaNCT02972970
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
A study testing Aveera in people with Obstructive Sleep Apnea, run by Metamason at 1 site in United States.
Trial summary
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Aveera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 16 May 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
- ≥ 18 years of age
- Both genders
- Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA
- Currently CPAP pillows and nasal mask users
- Patients who are adherent as defined by conventional standards (i.e. 4 hours per night/70% of the nights)
Who cannot join
- Unwilling to wear the AVEERA
- Concern about privacy of data
- Pregnant
- Full face mask user
- Any medical condition deemed by the investigator to pose an issue with the subject's participation.
- Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting of ≥17cm H2O
- Requires the use of supplemental oxygen
Trial locations and contacts
1 site in 1 country.
About this study
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
Read the detailed description
- Assess the process of scan, fit and print
- Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort
- Ethnographic insights into the user experience of the scan, fit, print process.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Aveera
- 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.
AveeraDevice
Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
| Study group | Role | What they receive |
|---|---|---|
| Aveera | Other | This is a prospective, open label study to assess the scan, print and fit process to see if the Aveera will be able to be used with conventional CPAP therapy devices Receives: Device: Aveera |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
Assess the clinical utility of using a 3D scanning process, printing and fit assessment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion16 May 2017
- Study completion16 May 2017
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metamason
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- robyn woidtke, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972970
- Sponsor's protocol ID
- Meta-001
- Status last verified
- Jun 2017
- First submitted
- 9 Nov 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: there is no plan to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
- ClinicalTrials.gov ID
- NCT02972970
- Acronym / sponsor ID
- Meta-001
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- MetamasonIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 25 Nov 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.
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
Detailed description
- Assess the process of scan, fit and print
- Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort
- Ethnographic insights into the user experience of the scan, fit, print process.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aveera | Other | Device: AveeraThis is a prospective, open label study to assess the scan, print and fit process to see if the Aveera will be able to be used with conventional CPAP therapy devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age
- Both genders
- Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA
- Currently CPAP pillows and nasal mask users
- Patients who are adherent as defined by conventional standards (i.e. 4 hours per night/70% of the nights)
Key exclusion criteria (7 listed)
- Unwilling to wear the AVEERA
- Concern about privacy of data
- Pregnant
- Full face mask user
- Any medical condition deemed by the investigator to pose an issue with the subject's participation.
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 |
|---|---|---|
| AveeraSubjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use | Device | Aveera |
Primary outcome
1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
Time frame: 2 weeks
Assess the clinical utility of using a 3D scanning process, printing and fit assessment
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 12 Jun 2017.
- Individual participant dataSharing planned: No. there is no plan to share individual data
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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.
robyn woidtke study director
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aveera in people with Obstructive Sleep Apnea, run by Metamason at 1 site in United States.
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 7 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 12 Jun 2017. 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 United States. 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?
1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit (time frame: 2 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 12 Jun 2017.