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

Pilairo Q In-lab Market Research - Europe

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: FPH Pilairo Q CPAP mask; Device: Any other market released nasal or nasal-pillow CPAP mask

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Herne, Germany, 44651
    • Evangelisches Krankenhaus Herne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FPH Pilairo Q CPAP mask; The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.	Device: FPH Pilairo Q CPAP mask; CPAP nasal-pillow mask; Other Names: FPH Pilairo CPAP mask; Pilairo Q; Pilairo
Active Comparator: 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	Device: Any other market released nasal or nasal-pillow CPAP mask; Any other market released nasal or nasal-pillow CPAP mask

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Martina Neddermann, Dr.med, Evangelisches Krankenhaus Herne

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIA-89