Obstructive Sleep ApneaNCT01824979
Pilairo Lab Market Research
A study testing CPAP mask ( Pilairo) and Other CPAP mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to observe the Pilairo mask in a lab setting. 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?
- CPAP mask ( Pilairo) and Other CPAP mask
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to May 2013
- 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
- Apnea Hypopnea Indea >15 from diagnostic study
- Minimum 18 years of age
Who cannot join
- Inability ot give informed consent
- History of intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
Trial locations and contacts
1 site in 1 country.
United States1 site
Peninsula Sleep Center Inc
Burlingame, California, 94010
About this study
The purpose of the study is to observe the Pilairo mask in a lab setting.
Read the detailed description
The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP mask ( Pilairo), Other 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.
CPAP mask ( Pilairo)Device
Other CPAP maskProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pilairo mask | Experimental | Pilairo nasal pillows mask during CPAP titration Receives: Device: CPAP mask ( Pilairo) |
| Other CPAP mask | Active comparator | Other CPAP mask during CPAP titration Receives: Procedure: Other CPAP mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technician Experience With Mask
Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
Measured: One night
Secondary outcomes (1)
Number of Mask Interventions During the Night
Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
Measured: One night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT01824979
- Sponsor's protocol ID
- CIA76
- Status last verified
- Feb 2018
- First submitted
- 2 Apr 2013
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilairo Lab Market Research
- ClinicalTrials.gov ID
- NCT01824979
- Acronym / sponsor ID
- CIA76
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 9 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to observe the Pilairo mask in a lab setting.
Detailed description
The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilairo mask | Experimental | Device: CPAP mask ( Pilairo)Pilairo nasal pillows mask during CPAP titration |
| Other CPAP mask | Active comparator | Procedure: Other CPAP maskOther CPAP mask during CPAP titration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apnea Hypopnea Indea >15 from diagnostic study
- Minimum 18 years of age
Key exclusion criteria (3 listed)
- Inability ot give informed consent
- History of intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
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 |
|---|---|---|
| CPAP mask ( Pilairo) | Device | Pilairo mask |
| Other CPAP mask | Procedure or surgery | Other CPAP mask |
Primary outcome
Technician Experience With Mask
Time frame: One night
Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
1 secondary outcome
Number of Mask Interventions During the Night
Time frame: One night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP mask ( Pilairo) and Other CPAP mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare 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 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 9 Mar 2018. 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?
Yes. Results are posted in the registry (first posted 9 Mar 2018). 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?
Technician Experience With Mask (time frame: One night). 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 9 Mar 2018.