Obstructive Sleep ApneaNCT02121912
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
A study testing FPH Pilairo Q CPAP mask and Any other market released nasal or nasal-pillow CPAP mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Germany.
Trial summary
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. 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?
- FPH Pilairo Q CPAP mask and Any other market released nasal or nasal-pillow CPAP mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- AHI equal or greater than 15 from the diagnostic night.
- Equal or greater than 18 years of age
Who cannot join
- Inability to give informed consent.
- History of intolerance to CPAP.
- Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilairo Q In-lab Market Research - Europe
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard masks for CPAP therapy in terms of ease of use, satisfaction and overall titration experience.
Read the detailed description
Participants will be recruited from patients who visit the sleep lab for CPAP titration. Only eligible participants, that provide written informed consent, will be enrolled into the investigation
Only those participants whom are previously diagnosed with an AHI >5 can be approached and enrolled into the study.
Once the consent form has been signed, participants will be randomly assigned to receive either Pilairo or any other standard care nasal/nasal pillows mask for their CPAP titration. A randomisation log will be provided by FPH.
The titration session will take place as per the lab's routine practice.
Throughout the night the Sleep Technician will record in the CRF the absolute leak value for the mask every 10 minutes.
At the end of the session the Sleep Technician will complete a questionnaire in relation to the titration experience for that participant/mask. The data will be collected in the CRF that FPH staff will provide to the site.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- FPH Pilairo Q CPAP mask, Any other market released nasal or nasal-pillow 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.
FPH Pilairo Q CPAP maskDevice
Also called FPH Pilairo CPAP mask, Pilairo Q, Pilairo
CPAP nasal-pillow mask
Any other market released nasal or nasal-pillow CPAP maskDevice
Any other market released nasal or nasal-pillow CPAP mask
| Study group | Role | What they receive |
|---|---|---|
| FPH Pilairo Q CPAP mask | Experimental | The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. Receives: Device: FPH Pilairo Q CPAP mask |
| Any other market released nasal or nasal-pillow CPAP mask | Active comparator | The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask Receives: Device: Any other market released nasal or nasal-pillow CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Questionnaire of Mask Experience
Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience
Measured: 1 night in the lab
Secondary outcomes (2)
Mask Leak
The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study.
Measured: Every 10min, for up to 8 hours
Sleep Technicians Recommendation to Use Mask
Sleep Technicians reported on whether they would recommend the mask to other professionals. Ratings were out of 1-10 and a higher score indicates a higher likelihood of recommending the mask.
Measured: 1 night in the lab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martina Neddermann, Dr.med, Principal investigator, Evangelisches Krankenhaus Herne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121912
- Sponsor's protocol ID
- CIA-89
- Status last verified
- Mar 2019
- First submitted
- 14 Apr 2014
- Last updated
- 24 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilairo Q In-lab Market Research - Europe
- ClinicalTrials.gov ID
- NCT02121912
- Acronym / sponsor ID
- CIA-89
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Posted 24 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard masks for CPAP therapy in terms of ease of use, satisfaction and overall titration experience.
Detailed description
Participants will be recruited from patients who visit the sleep lab for CPAP titration. Only eligible participants, that provide written informed consent, will be enrolled into the investigation
Only those participants whom are previously diagnosed with an AHI >5 can be approached and enrolled into the study.
Once the consent form has been signed, participants will be randomly assigned to receive either Pilairo or any other standard care nasal/nasal pillows mask for their CPAP titration. A randomisation log will be provided by FPH.
The titration session will take place as per the lab's routine practice.
Throughout the night the Sleep Technician will record in the CRF the absolute leak value for the mask every 10 minutes.
At the end of the session the Sleep Technician will complete a questionnaire in relation to the titration experience for that participant/mask. The data will be collected in the CRF that FPH staff will provide to the site.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FPH Pilairo Q CPAP mask | Experimental | Device: FPH Pilairo Q CPAP maskThe Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. |
| Any other market released nasal or nasal-pillow CPAP mask | Active comparator | Device: Any other market released nasal or nasal-pillow CPAP maskThe Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AHI equal or greater than 15 from the diagnostic night.
- Equal or greater than 18 years of age
Key exclusion criteria (3 listed)
- Inability to give informed consent.
- History of intolerance to CPAP.
- Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
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 |
|---|---|---|
| FPH Pilairo Q CPAP maskAlso: FPH Pilairo CPAP mask, Pilairo Q, PilairoCPAP nasal-pillow mask | Device | FPH Pilairo Q CPAP mask |
| Any other market released nasal or nasal-pillow CPAP maskAny other market released nasal or nasal-pillow CPAP mask | Device | Any other market released nasal or nasal-pillow CPAP mask |
Primary outcome
Subjective Questionnaire of Mask Experience
Time frame: 1 night in the lab
Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience
2 secondary outcomes
Mask Leak
Time frame: Every 10min, for up to 8 hours
Sleep Technicians Recommendation to Use Mask
Time frame: 1 night in the lab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Martina Neddermann, Dr.med principal investigator
Evangelisches Krankenhaus Herne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPH Pilairo Q CPAP mask and Any other market released nasal or nasal-pillow CPAP mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Germany.
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 2 inclusion and 3 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 24 Jun 2019. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjective Questionnaire of Mask Experience (time frame: 1 night in the lab). 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 24 Jun 2019.