Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilairo Q In-lab Market Research - Europe

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: FPH Pilairo Q CPAP mask
* Device: Any other market released nasal or nasal-pillow CPAP mask


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FPH Pilairo Q CPAP mask<br>The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant. | Device: FPH Pilairo Q CPAP mask<br>* CPAP nasal-pillow mask<br>* Other names: Pilairo;|
| Active Comparator: Any other market released nasal or nasal-pillow CPAP mask<br>The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask | Device: Any other market released nasal or nasal-pillow CPAP mask<br>* Any other market released nasal or nasal-pillow CPAP mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 night in the lab | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mask Leak | The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study. | 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. | 1 night in the lab |