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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FPH Pilairo Q CPAP mask
Any other market released nasal or nasal-pillow CPAP mask
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Evangelisches Krankenhaus Herne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FPH Pilairo Q CPAP mask

Any other market released nasal or nasal-pillow CPAP mask

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2014
Last Updated
March 19, 2019
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02121912
Brief Title
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Official Title
Pilairo Q In-lab Market Research - Europe
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FPH Pilairo Q CPAP mask
Arm Type
Experimental
Arm Description
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
Arm Title
Any other market released nasal or nasal-pillow CPAP mask
Arm Type
Active Comparator
Arm Description
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
Intervention Type
Device
Intervention Name(s)
FPH Pilairo Q CPAP mask
Other Intervention Name(s)
FPH Pilairo CPAP mask, Pilairo Q, Pilairo
Intervention Description
CPAP nasal-pillow mask
Intervention Type
Device
Intervention Name(s)
Any other market released nasal or nasal-pillow CPAP mask
Intervention Description
Any other market released nasal or nasal-pillow CPAP mask
Primary Outcome Measure Information:
Title
Subjective Questionnaire of Mask Experience
Description
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 Outcome Measure Information:
Title
Mask Leak
Description
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
Title
Sleep Technicians Recommendation to Use Mask
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Neddermann, Dr.med
Organizational Affiliation
Evangelisches Krankenhaus Herne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evangelisches Krankenhaus Herne
City
Herne
ZIP/Postal Code
44651
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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