Back to resultsThe Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Primary Purpose
Sleep Disordered Breathing, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
F&P Mask Seal
F&P Mask
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disordered Breathing
Eligibility Criteria
Inclusion Criteria:
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing oro-nasal mask user
Exclusion Criteria:
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness
- Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (CO2) retention
- Pregnant or may think they are pregnant
Sites / Locations
- Fisher & Paykel Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
F&P Mask Seal
F&P Mask
Arm Description
Participants to use trial seal in-home for 1 week
Participants to use trial mask in-home for 2 weeks
Outcomes
Primary Outcome Measures
Ease of use
Subjective questionnaire
Acceptability
Subjective questionnaire
Ease of use
Subjective questionnaire
Acceptability
Subjective questionnaire
Secondary Outcome Measures
Objective leak data
Obtained from participants' device
Full Information
NCT ID
NCT03092921
First Posted
March 22, 2017
Last Updated
August 6, 2017
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03092921
Brief Title
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Official Title
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (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
Yes
5. Study Description
Brief Summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
Detailed Description
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.
An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F&P Mask Seal
Arm Type
Experimental
Arm Description
Participants to use trial seal in-home for 1 week
Arm Title
F&P Mask
Arm Type
Experimental
Arm Description
Participants to use trial mask in-home for 2 weeks
Intervention Type
Device
Intervention Name(s)
F&P Mask Seal
Intervention Description
Investigative Mask Seal to be used for OSA therapy
Intervention Type
Device
Intervention Name(s)
F&P Mask
Intervention Description
Investigative Mask to be used for OSA therapy
Primary Outcome Measure Information:
Title
Ease of use
Description
Subjective questionnaire
Time Frame
1 week in home
Title
Acceptability
Description
Subjective questionnaire
Time Frame
1 week in home
Title
Ease of use
Description
Subjective questionnaire
Time Frame
2 weeks in home
Title
Acceptability
Description
Subjective questionnaire
Time Frame
2 weeks in home
Secondary Outcome Measure Information:
Title
Objective leak data
Description
Obtained from participants' device
Time Frame
1 week in home
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (18+ years of age)
Able to give consent
Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
Prescribed PAP for OSA
Existing oro-nasal mask user
Exclusion Criteria:
Inability to give consent
Patients who are in a coma or a decreased level of consciousness
Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
Commercial drivers who are investigated by New Zealand Transport Agency
Current diagnosis of carbon dioxide (CO2) retention
Pregnant or may think they are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Gunson
Organizational Affiliation
Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
For product development purposes only. Data will be deidentified.
Learn more about this trial
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
We'll reach out to this number within 24 hrs