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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121912

CIA-89

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

FPH Pilairo Q CPAP mask

Experimental group

Description:

The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.

Treatment:

Device: FPH Pilairo Q CPAP mask

Any other market released nasal or nasal-pillow CPAP mask

Active Comparator group

Description:

The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask

Treatment:

Device: Any other market released nasal or nasal-pillow CPAP mask