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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F&P Full-Face Mask | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F&P Full-Face Mask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Trial Mask Comfort | Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable). | 14 ± 5 days in-home |
| Participant Count of Acceptable Trial Mask Performance - Objective | Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective | 14 ± 5 days in-home |
| Trial Mask Seal Performance - Subjective | Determined from questionnaire - Subjective Uses a 5 point Likert Scale | 14 ± 5 days in-home |
| 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. | 14 ± 5 days in-home |
| 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. | 14 ± 5 days in-home |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 ± 5 days in-home |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ostransky, MD | Board Certified Sleep Specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Texas Lung and Sleep Clinic | Fort Worth | Texas | 76109 | United States |
IPD will not be shared with any other researchers or organizations.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| F&P Toffee Full Face Mask Validation |
| |||||||||||||
| Extension |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trial Mask Comfort | Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable). | Posted | Count of Participants | Participants | 14 ± 5 days in-home |
|
Adverse event data was collected over the 6 months the trial ran for (including the extension)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | F&P 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 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. Adverse event data will be collated for both arms of the trial for simplicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Blood and lymphatic system disorders | Non-systematic Assessment | Admitted to ER, was note related to the trial and resolved no sequel |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Irritations were present whilst using their usual mask so reported as not related and resolved no sequel |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanie Yee | Fisher & Paykel Healthcare | +64 9 574 0123 | 7909 | Hanie.Yee@fphcare.co.nz |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2017 | Jun 2, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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After a period of baseline, all enrolled participants will be put on the same trial mask.
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|
| Participant Count of Seal Size Determination |
Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction. |
| 1 day-time appointment (1 hour) Visit 2 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Participant Count of Acceptable Trial Mask Performance - Objective | Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective | Posted | Count of Participants | Participants | 14 ± 5 days in-home |
|
|
|
| Primary | Trial Mask Seal Performance - Subjective | Determined from questionnaire - Subjective Uses a 5 point Likert Scale | Posted | Count of Participants | Participants | 14 ± 5 days in-home |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 ± 5 days in-home |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 ± 5 days in-home |
|
|
|
| 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. | Posted | Count of Participants | Participants | 14 ± 5 days in-home |
|
|
|
| Secondary | Participant Count of Seal Size Determination | Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction. | Posted | Count of Participants | Participants | 1 day-time appointment (1 hour) Visit 2 |
|
|
|
| 0 |
| 42 |
| 2 |
| 42 |
| 2 |
| 42 |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | Admitted to ICU. Not related to trial and resolved no sequel |
|
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Poor |
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| Very poor |
|
| N/A |
|
| Hard |
|
| Very hard |
|
| Title | Measurements |
|---|
|
| Hard |
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| Very hard |
|
| Title | Measurements |
|---|
|