Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Pilairo Q In-lab Market Research - Europe
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
June 24, 2019
CompletedJune 24, 2019
March 1, 2019
5 months
April 14, 2014
July 25, 2017
March 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mask Leak
Every 10min, for up to 8 hours
Sleep Technicians Recommendation to Use Mask
1 night in the lab
Study Arms (2)
FPH Pilairo Q CPAP mask
EXPERIMENTALThe Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
Any other market released nasal or nasal-pillow CPAP mask
ACTIVE COMPARATORThe Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Interventions
CPAP nasal-pillow mask
Any other market released nasal or nasal-pillow CPAP mask
Eligibility Criteria
You may qualify if:
- AHI equal or greater than 15 from the diagnostic night.
- Equal or greater than 18 years of age
You may not qualify if:
- Inability to give informed consent.
- History of intolerance to CPAP.
- Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evangelisches Krankenhaus Herne
Herne, 44651, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Scientist
- Organization
- Fisher and Paykel Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Martina Neddermann, Dr.med
Evangelisches Krankenhaus Herne
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 24, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2014
Study Completion
April 1, 2016
Last Updated
June 24, 2019
Results First Posted
June 24, 2019
Record last verified: 2019-03