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

Obstructive Sleep Apnea Clinical Trial

Official title:

Pilairo Q In-lab Market Research - Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121912
• Other study ID #: CIA-89
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2019
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• FPH Pilairo Q CPAP mask
CPAP nasal-pillow mask
• Any other market released nasal or nasal-pillow CPAP mask
Any other market released nasal or nasal-pillow CPAP mask

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Herne	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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