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OpenTrials
Completed

NCT Number: NCT02121912

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelisches Krankenhaus Herne

Herne, 44651, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FPH Pilairo Q CPAP mask

Device

CPAP nasal-pillow mask

Other names: FPH Pilairo CPAP mask, Pilairo Q, Pilairo

Any other market released nasal or nasal-pillow CPAP mask

Device

Any other market released nasal or nasal-pillow CPAP mask

Primary outcomes

  1. Subjective Questionnaire of Mask Experience

    Time frame: 1 night in the lab

    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

Secondary outcomes

  1. Mask Leak

    Time frame: Every 10min, for up to 8 hours

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

  2. Sleep Technicians Recommendation to Use Mask

    Time frame: 1 night in the lab

    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.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

Pilairo Q In-lab Market Research - Europe

Important dates

Study start
2014
Primary completion
2014
Study completion
2016
First posted
Apr 24, 2014
Registry last updated
Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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