Obstructive Sleep ApneaNCT02540603
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
A study testing F&P Jupiter Full Face Mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare.
Trial summary
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants. 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?
- F&P Jupiter Full Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- 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
- Diagnosed with OSA by a practicing physician
- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
- Existing full face users
Who cannot join
- Inability to give informed consent
- Patients who are in a coma or decreased level of consciousness
- Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
- Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
- Pregnant or think they may be pregnant
About this study
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.
Read the detailed description
A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- F&P Jupiter Full Face 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.
F&P Jupiter Full Face MaskDevice
Also called Jupiter Mask
Investigative F\&P Jupiter full face mask to be used for OSA therapy
| Study group | Role | What they receive |
|---|---|---|
| Full Face Mask | Experimental | F\&P Jupiter Full Face Mask with Headgear Receives: Device: F&P Jupiter Full Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with average system leak >60L/min
Average system leak will be recorded through downloading of the data from the PAP device in L/min.
Measured: Two weeks in-home use
Secondary outcomes (2)
Insights into mask fitting and removal.
Observations of the action of fitting the mask and removing the mask will be noted.
Measured: Two weeks use
Number of participants that found the mask comfortable.
Subjective feedback on comfort will be measured through questionnaires.
Measured: Two weeks in-home use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionDec 2015
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 Fisher and Paykel HealthcareThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540603
- Sponsor's protocol ID
- CIA-179
- Status last verified
- Apr 2017
- First submitted
- 28 Aug 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared to any other parties.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
- ClinicalTrials.gov ID
- NCT02540603
- Acronym / sponsor ID
- CIA-179
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Sep 2015 (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.
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.
Detailed description
A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Face Mask | Experimental | Device: F&P Jupiter Full Face MaskF\&P Jupiter Full Face Mask with Headgear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18+ years of age
- Diagnosed with OSA by a practicing physician
- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
- Existing full face users
Key exclusion criteria (6 listed)
- Inability to give informed consent
- Patients who are in a coma or decreased level of consciousness
- Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
- Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
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 |
|---|---|---|
| F&P Jupiter Full Face MaskAlso: Jupiter MaskInvestigative F\&P Jupiter full face mask to be used for OSA therapy | Device | Full Face Mask |
Primary outcome
Number of participants with average system leak >60L/min
Time frame: Two weeks in-home use
Average system leak will be recorded through downloading of the data from the PAP device in L/min.
2 secondary outcomes
Insights into mask fitting and removal.
Time frame: Two weeks use
Number of participants that found the mask comfortable.
Time frame: Two weeks in-home 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 20 Apr 2017.
- Individual participant dataSharing planned: No. Data will be shared to any other parties.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing F&P Jupiter Full Face Mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare.
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 4 inclusion and 6 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 20 Apr 2017. 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 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?
Number of participants with average system leak >60L/min (time frame: Two weeks in-home 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 20 Apr 2017.