Back to resultsEvaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
F&P Jupiter Full Face Mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- 18+ years of age
- Diagnosed with OSA by a practicing physician
- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
- Existing full face users
Exclusion Criteria:
- Inability to give informed consent
- Patients who are in a coma or decreased level of consciousness
- Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
- Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
- Pregnant or think they may be pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Full Face Mask
Arm Description
F&P Jupiter Full Face Mask with Headgear
Outcomes
Primary Outcome Measures
Number of participants with average system leak >60L/min
Average system leak will be recorded through downloading of the data from the PAP device in L/min.
Secondary Outcome Measures
Insights into mask fitting and removal.
Observations of the action of fitting the mask and removing the mask will be noted.
Number of participants that found the mask comfortable.
Subjective feedback on comfort will be measured through questionnaires.
Full Information
NCT ID
NCT02540603
First Posted
August 28, 2015
Last Updated
April 18, 2017
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02540603
Brief Title
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Official Title
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.
Detailed Description
A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full Face Mask
Arm Type
Experimental
Arm Description
F&P Jupiter Full Face Mask with Headgear
Intervention Type
Device
Intervention Name(s)
F&P Jupiter Full Face Mask
Other Intervention Name(s)
Jupiter Mask
Intervention Description
Investigative F&P Jupiter full face mask to be used for OSA therapy
Primary Outcome Measure Information:
Title
Number of participants with average system leak >60L/min
Description
Average system leak will be recorded through downloading of the data from the PAP device in L/min.
Time Frame
Two weeks in-home use
Secondary Outcome Measure Information:
Title
Insights into mask fitting and removal.
Description
Observations of the action of fitting the mask and removing the mask will be noted.
Time Frame
Two weeks use
Title
Number of participants that found the mask comfortable.
Description
Subjective feedback on comfort will be measured through questionnaires.
Time Frame
Two weeks in-home use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18+ years of age
Diagnosed with OSA by a practicing physician
Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
Existing full face users
Exclusion Criteria:
Inability to give informed consent
Patients who are in a coma or decreased level of consciousness
Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
Current diagnosis of CO2 retention
Pregnant or think they may be pregnant
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared to any other parties.
Learn more about this trial
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
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