Obstructive Sleep Apnea
Conditions
Brief summary
The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed description
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months. The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea. Neither the investigators nor the participants will be blinded to the study. Data from initial 2 week trial is reported here.
Interventions
DEVICEF&P Full-Face Mask
The F&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After a period of baseline, all enrolled participants will be put on the same trial mask.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AHI ≥ 5 from diagnostic PSG night * Aged 22 and over (FDA defined as adult) * Either prescribed APAP, CPAP or Bi-Level PAP for OSA * Existing full-face mask users * Fluent in spoken and written English
Exclusion criteria
* Inability to give informed consent * Patient intolerant to CPAP therapy * Anatomical or physiological conditions making PAP therapy inappropriate * Current diagnosis of respiratory disease or CO2 retention * Pregnant or think they may be pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Count of Acceptable Trial Mask Performance - Objective | 14 ± 5 days in-home | Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective |
| Trial Mask Ease of Cleaning | 14 ± 5 days in-home | Determined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard. |
| Trial Mask Ease-of-use | 14 ± 5 days in-home | Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort. |
| Trial Mask Comfort | 14 ± 5 days in-home | Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable). |
| Trial Mask Seal Performance - Subjective | 14 ± 5 days in-home | Determined from questionnaire - Subjective Uses a 5 point Likert Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Count of Seal Size Determination | 1 day-time appointment (1 hour) Visit 2 | Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction. |
| Participant Count of Acceptable Mask Leak | 14 ± 5 days in-home | Data recorded from PAP device reporting amount of air leaking from the mask during PAP therapy. If mask leak was over 60 L/min it was compared to the participants baseline leak values to assess if mask leak with the trial mask was acceptable or not. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| F&P Toffee Full-Face Mask Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.
F&P Toffee Full-Face Mask: The F&P Toffee Full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | F&P Toffee Full-Face Mask |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 2 / 42 |
| serious Total, serious adverse events | 2 / 42 |
Outcome results
Primary
Participant Count of Acceptable Trial Mask Performance - Objective
Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Time frame: 14 ± 5 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Participant Count of Acceptable Trial Mask Performance - Objective | Pass | 34 Participants |
| F&P Toffee Full-Face Mask | Participant Count of Acceptable Trial Mask Performance - Objective | Fail | 0 Participants |
| F&P Toffee Full-Face Mask | Participant Count of Acceptable Trial Mask Performance - Objective | N/A | 8 Participants |
Primary
Trial Mask Comfort
Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Time frame: 14 ± 5 days in-home
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Trial Mask Comfort | Very comfortable | 20 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Comfort | Comfortable | 16 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Comfort | Neutral | 4 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Comfort | Uncomfortable | 1 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Comfort | Very uncomfortable | 0 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Comfort | N/A | 1 Participants |
Primary
Trial Mask Ease of Cleaning
Determined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.
Time frame: 14 ± 5 days in-home
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Trial Mask Ease of Cleaning | Very easy | 25 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease of Cleaning | Easy | 15 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease of Cleaning | Neutral | 2 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease of Cleaning | Hard | 0 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease of Cleaning | Very hard | 0 Participants |
Primary
Trial Mask Ease-of-use
Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.
Time frame: 14 ± 5 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Trial Mask Ease-of-use | Very easy | 27 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease-of-use | Easy | 14 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease-of-use | Neutral | 1 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease-of-use | Hard | 0 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Ease-of-use | Very hard | 0 Participants |
Primary
Trial Mask Seal Performance - Subjective
Determined from questionnaire - Subjective Uses a 5 point Likert Scale
Time frame: 14 ± 5 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Trial Mask Seal Performance - Subjective | Very good | 17 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Seal Performance - Subjective | Good | 14 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Seal Performance - Subjective | Neutral | 4 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Seal Performance - Subjective | Poor | 4 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Seal Performance - Subjective | Very poor | 2 Participants |
| F&P Toffee Full-Face Mask | Trial Mask Seal Performance - Subjective | N/A | 1 Participants |
Secondary
Participant Count of Acceptable Mask Leak
Data recorded from PAP device reporting amount of air leaking from the mask during PAP therapy. If mask leak was over 60 L/min it was compared to the participants baseline leak values to assess if mask leak with the trial mask was acceptable or not.
Time frame: 14 ± 5 days in-home
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Participant Count of Acceptable Mask Leak | Pass | 30 Participants |
| F&P Toffee Full-Face Mask | Participant Count of Acceptable Mask Leak | Fail | 4 Participants |
| F&P Toffee Full-Face Mask | Participant Count of Acceptable Mask Leak | N/A | 8 Participants |
Secondary
Participant Count of Seal Size Determination
Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.
Time frame: 1 day-time appointment (1 hour) Visit 2
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| F&P Toffee Full-Face Mask | Participant Count of Seal Size Determination | Pass | 28 Participants |
| F&P Toffee Full-Face Mask | Participant Count of Seal Size Determination | Fail | 16 Participants |