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

N/ACompletedNCT02121912

Fisher and Paykel Healthcare50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

FPH Pilairo Q CPAP maskDEVICE

CPAP nasal-pillow mask

Any other market released nasal or nasal-pillow CPAP maskDEVICE

Any other market released nasal or nasal-pillow CPAP mask

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Evangelisches Krankenhaus Herne

Herne, Germany

Outcomes

Primary Outcomes

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

Time frame: 1 night in the lab

Secondary Outcomes

Mask Leak

The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study.

Time frame: 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.

Time frame: 1 night in the lab

Data from ClinicalTrials.gov

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