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

NCT ID: NCT02121912

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

FPH Pilairo Q CPAP mask

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

Group Type: EXPERIMENTAL

FPH Pilairo Q CPAP mask

Intervention Type: DEVICE

CPAP nasal-pillow mask

Any other market released nasal or nasal-pillow CPAP mask

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

Group Type: ACTIVE_COMPARATOR

Any other market released nasal or nasal-pillow CPAP mask

Intervention Type: DEVICE

Any other market released nasal or nasal-pillow CPAP mask

Interventions

FPH Pilairo Q CPAP mask

CPAP nasal-pillow mask

Intervention Type: DEVICE

Any other market released nasal or nasal-pillow CPAP mask

Any other market released nasal or nasal-pillow CPAP mask

Intervention Type: DEVICE

Other Intervention Names

FPH Pilairo CPAP mask; Pilairo Q; Pilairo

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martina Neddermann, Dr.med

Role: PRINCIPAL_INVESTIGATOR

Evangelisches Krankenhaus Herne

Locations

Evangelisches Krankenhaus Herne

Herne, , Germany

Countries

Germany

Other Identifiers

CIA-89

Identifier Type: -

Identifier Source: org_study_id