Sleep Disordered BreathingNCT02894242
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
A study testing F&P Deimos Nasal Pillows 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 designed to evaluate the performance as well as the patients overall acceptance of the mask. 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?
- F&P Deimos Nasal Pillows Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Sep 2016to Mar 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
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing nasal pillows user
Who cannot join
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness
- Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (CO2) retention
- Pregnant or may think they are pregnant
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Fisher and Paykel Healthcare
Auckland, 2013
Hawkes Bay Fallen Soldiers' Memorial Hospital
Hastings, 4120
About this study
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
Read the detailed description
A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.
- Being tested
- F&P Deimos Nasal Pillows 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.
F&P Deimos Nasal Pillows MaskDevice
Also called Deimos Mask
Investigative Nasal Pillows Mask to be used for OSA therapy
| Study group | Role | What they receive |
|---|---|---|
| F&P Deimos Nasal Pillows Mask | Experimental | Participants to use nasal pillows mask in-home for 2 weeks. Receives: Device: F&P Deimos Nasal Pillows Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use
Subjective questionnaire
Measured: 2 weeks in home
Acceptability
Subjective questionnaire
Measured: 2 weeks in home
Secondary outcomes (1)
Objective leak data
Obtained from participants' device
Measured: 2 weeks in home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionMar 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Gunson, Bsc PgDip, Principal investigator, Sponsor Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894242
- Sponsor's protocol ID
- CIA-197
- Status last verified
- Apr 2017
- First submitted
- 5 Sep 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: For product development purposes only. Data will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02894242
- Acronym / sponsor ID
- CIA-197
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Sep 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 designed to evaluate the performance as well as the patients overall acceptance of the mask.
Detailed description
A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the 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 |
|---|---|---|
| F&P Deimos Nasal Pillows Mask | Experimental | Device: F&P Deimos Nasal Pillows MaskParticipants to use nasal pillows mask in-home for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing nasal pillows user
Key exclusion criteria (6 listed)
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness
- Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (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 Deimos Nasal Pillows MaskAlso: Deimos MaskInvestigative Nasal Pillows Mask to be used for OSA therapy | Device | F&P Deimos Nasal Pillows Mask |
Primary outcome
Ease of use
Time frame: 2 weeks in home
Subjective questionnaire
Acceptability
Time frame: 2 weeks in home
Subjective questionnaire
1 secondary outcome
Objective leak data
Time frame: 2 weeks 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 4 Apr 2017.
- Individual participant dataSharing planned: No. For product development purposes only. Data will be deidentified.
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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.
Sarah Gunson, Bsc PgDip 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 F&P Deimos Nasal Pillows 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 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 4 Apr 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?
Ease of use (time frame: 2 weeks in home). The study lists 2 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 4 Apr 2017.