Obstructive Sleep Apnea, Positive Airway Pressure Therapy
Conditions
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.
Interventions
DEVICEToffee Full Face Mask
Full face mask for PAP therapy applied in a home environment
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort - Subjective | Assessed 2 weeks after mask fitting | 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 | Assessed 2 weeks after mask fitting | 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 | Assessed 2 weeks after mask fitting | 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. |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Toffee Full Face Mask Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Toffee Full Face Mask |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment New Zealand | 44 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 10 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
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.
Time frame: Assessed 2 weeks after mask fitting
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Comfort - Subjective | Very comfortable | 18 Participants |
| Toffee Full Face Mask | Comfort - Subjective | Uncomfortable | 2 Participants |
| Toffee Full Face Mask | Comfort - Subjective | Comfortable | 23 Participants |
| Toffee Full Face Mask | Comfort - Subjective | Very uncomfortable | 1 Participants |
Primary
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.
Time frame: Assessed 2 weeks after mask fitting
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Seal Performance | Very poor | 0 Participants |
| Toffee Full Face Mask | Seal Performance | Poor | 4 Participants |
| Toffee Full Face Mask | Seal Performance | Very good | 25 Participants |
| Toffee Full Face Mask | Seal Performance | Good | 15 Participants |
Primary
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.
Time frame: Assessed 2 weeks after mask fitting
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toffee Full Face Mask | Usability | Very easy | 19 Participants |
| Toffee Full Face Mask | Usability | Easy | 23 Participants |
| Toffee Full Face Mask | Usability | Difficult | 2 Participants |
| Toffee Full Face Mask | Usability | Very difficult | 0 Participants |