An interventional study of CPAP mask ( Pilairo) and Other CPAP mask in Obstructive Sleep Apnea, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by Fisher and Paykel Healthcare · Not applicable, Interventional, and Treatment
The purpose of the study is to observe the Pilairo mask in a lab setting.
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 100 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Fisher and Paykel Healthcare is the lead sponsor of 86 studies on the registry; 16 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
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Exclusion Criteria:
Pilairo nasal pillows mask during CPAP titration
Device: CPAP mask ( Pilairo)
Other CPAP mask during CPAP titration
Procedure: Other CPAP mask
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.
Time frame: One night
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.
Time frame: One night
| Milestone | Pilairo | Other CPAP Mask |
|---|---|---|
| Started | 50 | 50 |
| Completed | 37 | 37 |
| Not completed | 13 | 13 |
| Withdrew: Withdrawal by subject | 5 | 0 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Protocol violation | 6 | 13 |
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.
| Units on a Scale | Pilairo | Other CPAP Mask |
|---|---|---|
| Technician Experience With Mask | 8.46 (0 to 10) | 8.24 (0 to 10) |
Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
| units on a scale | Pilairo | Other CPAP Mask |
|---|---|---|
| Number of Mask Interventions During the Night | 1.29 (0 to 5) | 2.20 (0 to 5) |
Collected over 1 night in lab. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilairo | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Other CPAP Mask | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Customized(Participants) | Pilairo | Other CPAP Mask | Total |
|---|---|---|---|
| ≥ 18 years | 50 | 50 | 100 |
| Sex: Female, Male(Participants) | Pilairo | Other CPAP Mask | Total |
|---|---|---|---|
| Female | 10 | 19 | 29 |
| Male | 40 | 31 | 71 |
| Region of Enrollment(Participants) | Pilairo | Other CPAP Mask | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
The record gives a start of Dec 2012, a primary completion of May 2013 and a completion of May 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2018, 4 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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