Back to resultsF&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Primary Purpose
Positive Airway Pressure Therapy, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Toffee Full Face Mask
Sponsored by
About this trial
This is an interventional treatment trial for Positive Airway Pressure Therapy
Eligibility Criteria
Inclusion Criteria:
- Persons who are ≥ 22 years of age
- Persons who weigh ≥ 66 lbs (30 kgs)
- Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
- Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
- Persons who are currently using a full face mask
- Persons who have an IPAP pressure of < 30 cmH2O
- Persons who currently use a PAP therapy device with data recording capabilities
- Persons who are fluent in spoken and written English
- Persons who possess the capacity to provide informed consent
Exclusion Criteria:
- Persons who are intolerant to PAP therapy
- Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
- Persons using nasal or nasal pillows masks
- Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- Persons who are pregnant or think they may be pregnant
- Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
- Persons who currently have cold or flu like symptoms at the time of recruitment
- Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment
Sites / Locations
- Hastings Memorial Hospital
- Fisher & Paykel Healthcare
- Bowen Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toffee Full Face Mask
Arm Description
Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks.
Outcomes
Primary Outcome Measures
Comfort - Subjective
To assess the comfort of the mask as experienced by the participant. Comfort will be measured on a 4 point likert type scale (options: Very Uncomfortable, Uncomfortable, Comfortable, and Very Comfortable). Very Comfortable will be scored the highest and Very Uncomfortable will be scored the lowest. Different aspects of the mask such as cushion comfort, headgear comfort and overall comfort will be assessed using the same scale. Questions will be asked on a questionnaire and further qualitative responses will be captured during an interview.
Usability
To assess the ease of use of the mask as experienced by the participant. Questions regarding the freedom of movement in bed will be asked using a 4 point likert type scale (options: Very Difficult, Difficult, Easy, and Very Easy). Very Easy will be scored the highest and Very Difficult will be scored the lowest. Questions will be asked via a questionnaire with additional qualitative responses captured during an interview.
Seal Performance
To assess the sealing performance of the mask when used in a home environment. Questions regarding the seal performance will be asked using a 4 point likert type scale (options: Very poor, Poor, Good, and Very good). Very good will be scored the highest and Very poor will be scored the lowest.
Secondary Outcome Measures
Full Information
NCT ID
NCT04615832
First Posted
October 28, 2020
Last Updated
November 29, 2021
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT04615832
Brief Title
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Official Title
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (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
5. Study Description
Brief Summary
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.
Detailed Description
The purpose of this clinical investigation was to evaluate the performance, comfort and ease of use of the F&P Toffee Full Face Mask. The clinical investigation took place across three sites in order to recruit the required number of participants. The clinical investigation tested the mask on 44 participants, who were currently using a full face mask for PAP therapy.
This was a non-randomized non-blinded single intervention study. Informed consent was gathered from the 44 participants before demographic and baseline measurements were recorded. Participants were issued an appropriate fitting Toffee Full face mask for the two week at home trial.
After two weeks the participants returned the masks. At this visit device data was downloaded and participant questionnaires were completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive Airway Pressure Therapy, 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
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toffee Full Face Mask
Arm Type
Experimental
Arm Description
Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Toffee Full Face Mask
Intervention Description
Full face mask for PAP therapy applied in a home environment
Primary Outcome Measure Information:
Title
Comfort - Subjective
Description
To assess the comfort of the mask as experienced by the participant. Comfort will be measured on a 4 point likert type scale (options: Very Uncomfortable, Uncomfortable, Comfortable, and Very Comfortable). Very Comfortable will be scored the highest and Very Uncomfortable will be scored the lowest. Different aspects of the mask such as cushion comfort, headgear comfort and overall comfort will be assessed using the same scale. Questions will be asked on a questionnaire and further qualitative responses will be captured during an interview.
Time Frame
Assessed 2 weeks after mask fitting
Title
Usability
Description
To assess the ease of use of the mask as experienced by the participant. Questions regarding the freedom of movement in bed will be asked using a 4 point likert type scale (options: Very Difficult, Difficult, Easy, and Very Easy). Very Easy will be scored the highest and Very Difficult will be scored the lowest. Questions will be asked via a questionnaire with additional qualitative responses captured during an interview.
Time Frame
Assessed 2 weeks after mask fitting
Title
Seal Performance
Description
To assess the sealing performance of the mask when used in a home environment. Questions regarding the seal performance will be asked using a 4 point likert type scale (options: Very poor, Poor, Good, and Very good). Very good will be scored the highest and Very poor will be scored the lowest.
Time Frame
Assessed 2 weeks after mask fitting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons who are ≥ 22 years of age
Persons who weigh ≥ 66 lbs (30 kgs)
Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
Persons who are currently using a full face mask
Persons who have an IPAP pressure of < 30 cmH2O
Persons who currently use a PAP therapy device with data recording capabilities
Persons who are fluent in spoken and written English
Persons who possess the capacity to provide informed consent
Exclusion Criteria:
Persons who are intolerant to PAP therapy
Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
Persons using nasal or nasal pillows masks
Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
Persons who are pregnant or think they may be pregnant
Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2
Persons who currently have cold or flu like symptoms at the time of recruitment
Persons who have tested positive for COVID-19 within the previous 28 days prior to enrolment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra
Organizational Affiliation
Fisher & Paykel Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hastings Memorial Hospital
City
Hastings
State/Province
Hawkes Bay
ZIP/Postal Code
1420
Country
New Zealand
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
Facility Name
Bowen Hospital
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
We'll reach out to this number within 24 hrs