Back to resultsPilairo Lab Market Research
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP mask ( Pilairo)
Other CPAP mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Apnea Hypopnea Indea >15 from diagnostic study
- Minimum 18 years of age
Exclusion Criteria:
- Inability ot give informed consent
- History of intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
Sites / Locations
- Peninsula Sleep Center Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pilairo mask
Other CPAP mask
Arm Description
Pilairo nasal pillows mask during CPAP titration
Other CPAP mask during CPAP titration
Outcomes
Primary Outcome Measures
Technician Experience With Mask
Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
Secondary Outcome Measures
Number of Mask Interventions During the Night
Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
Full Information
NCT ID
NCT01824979
First Posted
April 2, 2013
Last Updated
February 8, 2018
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT01824979
Brief Title
Pilairo Lab Market Research
Official Title
Pilairo Lab Market Research
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (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
The purpose of the study is to observe the Pilairo mask in a lab setting.
Detailed Description
The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilairo mask
Arm Type
Experimental
Arm Description
Pilairo nasal pillows mask during CPAP titration
Arm Title
Other CPAP mask
Arm Type
Active Comparator
Arm Description
Other CPAP mask during CPAP titration
Intervention Type
Device
Intervention Name(s)
CPAP mask ( Pilairo)
Intervention Type
Procedure
Intervention Name(s)
Other CPAP mask
Primary Outcome Measure Information:
Title
Technician Experience With Mask
Description
Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
Time Frame
One night
Secondary Outcome Measure Information:
Title
Number of Mask Interventions During the Night
Description
Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
Time Frame
One night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Apnea Hypopnea Indea >15 from diagnostic study
Minimum 18 years of age
Exclusion Criteria:
Inability ot give informed consent
History of intolerance to CPAP
Anatomical or physiological conditions making CPAP therapy inappropriate
Facility Information:
Facility Name
Peninsula Sleep Center Inc
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilairo Lab Market Research
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