N/A
Completed N=50
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Source: ClinicalTrials.gov NCT02121912 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Subjective Questionnaire of Mask Experience — 8.08; 8.12 units on a scale
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Questionnaire of Mask Experience |
8.08; 8.12 | — |
| SECONDARY Mask Leak |
38.36; 35.47 | — |
| SECONDARY Sleep Technicians Recommendation to Use Mask |
8.83; 8.17 | — |
Eligibility Criteria
Inclusion Criteria
- AHI equal or greater than 15 from the diagnostic night.
- Equal or greater than 18 years of age
Exclusion Criteria
- Inability to give informed consent.
- History of intolerance to CPAP.
- Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
Data sourced from ClinicalTrials.gov (NCT02121912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.