Sleep Disordered BreathingNCT02938208
An Investigation to Test a Prototype Full-face Mask in the Home Setting
A study testing Jupiter Full Face Mask in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
Trial summary
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea
- What is being tested?
- Jupiter Full Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 3 Nov 2016to 31 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
- Diagnosed with OSA by a practicing physician
- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)
- Existing full face mask users
- Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).
Who cannot join
- Inability to give informed consent
- 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
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Fisher & Paykel Healthcare
Auckland, 2013
Wellsleep: Bowen Hospital
Wellington, 6035
About this study
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.
Read the detailed description
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ).
Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask.
Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
- Being tested
- Jupiter Full Face Mask
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jupiter Full Face MaskDevice
Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.
| Study group | Role | What they receive |
|---|---|---|
| Jupiter Full Face Mask | Experimental | Participants to use full face mask in-home for a 14 ± 3 days in-home. Receives: Device: Jupiter Full Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective mask leak data measurement (System Leak)
Obtained from participant's CPAP device, measured in L/min
Measured: Up to 21 ± 6 days in-home
Subjective Measurement of leak assessed using a Subjective Questionnaire
Subjective Questionnaire
Measured: Up to 21 ± 6 days in-home
Comfort assessed using a Subjective Questionnaire
Subjective Questionnaire
Measured: Up to 21 ± 6 days in-home
Stability assessed using a Subjective Questionnaire
Subjective Questionnaire
Measured: Up to 21 ± 6 days in-home
Draft assessed using a Subjective Questionnaire
Subjective Questionnaire
Measured: Up to 21 ± 6 days in-home
Noise assessed using a Subjective Questionnaire
Subjective Questionnaire
Measured: Up to 21 ± 6 days in-home
Secondary outcomes (2)
Preference of Mask assessed using a Subjective Questionnaire
Subjective Questionnaire
Measured: Up to 21 ± 6 days in-home
Usability via mask unboxing/fitting exercise with a subjective questionnaire
Usability activity during visit 2 with subjective questionnaire after activity
Measured: Up to 21 ± 6 days in-home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start3 Nov 2016
- Primary completion21 Nov 2016
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kayan Gonda, BSc, Principal investigator, Sponsor Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938208
- Sponsor's protocol ID
- CIA-198
- Status last verified
- Jul 2017
- First submitted
- 16 Oct 2016
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is an investigation for a prototype full face mask. The results from this trial will feedback into product development on further improving the full face mask for future trials and impending release of the product.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation to Test a Prototype Full-face Mask in the Home Setting
- ClinicalTrials.gov ID
- NCT02938208
- Acronym / sponsor ID
- CIA-198
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 19 Oct 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.
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.
Detailed description
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ).
Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask.
Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jupiter Full Face Mask | Experimental | Device: Jupiter Full Face MaskParticipants to use full face mask in-home for a 14 ± 3 days in-home. |
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
- Diagnosed with OSA by a practicing physician
- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)
- Existing full face mask users
- Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).
Key exclusion criteria (5 listed)
- Inability to give informed consent
- 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
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 |
|---|---|---|
| Jupiter Full Face MaskFull Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy. | Device | Jupiter Full Face Mask |
Primary outcome
Objective mask leak data measurement (System Leak)
Time frame: Up to 21 ± 6 days in-home
Obtained from participant's CPAP device, measured in L/min
Subjective Measurement of leak assessed using a Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Subjective Questionnaire
Comfort assessed using a Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Subjective Questionnaire
Stability assessed using a Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Subjective Questionnaire
Draft assessed using a Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Subjective Questionnaire
Noise assessed using a Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Subjective Questionnaire
2 secondary outcomes
Preference of Mask assessed using a Subjective Questionnaire
Time frame: Up to 21 ± 6 days in-home
Usability via mask unboxing/fitting exercise with a subjective questionnaire
Time frame: Up to 21 ± 6 days in-home
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 25 Jul 2017.
- Individual participant dataSharing planned: No. This is an investigation for a prototype full face mask. The results from this trial will feedback into product development on further improving the full face mask for future trials and impending release of the product.
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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.
Kayan Gonda, BSc principal investigator
Sponsor Employee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jupiter Full Face Mask in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
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 5 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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?
Objective mask leak data measurement (System Leak) (time frame: Up to 21 ± 6 days in-home). The study lists 6 primary outcomes in all. 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 25 Jul 2017.