NCT02121912

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

Pilairo Q In-lab Market Research - Europe

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	FPH Pilairo Q CPAP mask	CPAP nasal-pillow mask
DEVICE	Any other market released nasal or nasal-pillow CPAP mask	Any other market released nasal or nasal-pillow CPAP mask

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-11-01
• Completion: 2016-04-01
• First posted: 2014-04-24
• Last updated: 2019-06-24
• Results posted: 2019-06-24

Locations

1 site across 1 country: Germany