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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toffee Full Face Mask | Experimental | Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toffee Full Face Mask | Device | Full face mask for PAP therapy applied in a home environment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed 2 weeks after mask fitting |
| 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. | Assessed 2 weeks after mask fitting |
| 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. | Assessed 2 weeks after mask fitting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhavi Ogra | Fisher & Paykel Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hastings Memorial Hospital | Hastings | Hawkes Bay | 1420 | New Zealand | ||
| Fisher & Paykel Healthcare |
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| ID | Title | Description |
|---|---|---|
| FG000 | Toffee Full Face Mask | Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toffee Full Face Mask | Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment |
| 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 | 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. | Posted | Count of Participants | Participants | Assessed 2 weeks after mask fitting |
|
Adverse event data was collected during the 2 week duration of the study period.
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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 | Toffee Full Face Mask | Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment for 2 weeks. Toffee Full Face Mask: Full face mask for PAP therapy applied in a home environment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal soreness | Injury, poisoning and procedural complications | Systematic Assessment | Due to previous nasal surgery. Not related, resolved no sequel. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bhavi Ogra | Fisher & Paykel Healthcare Ltd. | +64 9 574 0123 | 7882 | bhavi.ogra@fphcare.co.nz |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2021 | Jul 26, 2021 | Prot_SAP_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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| Auckland |
| 2013 |
| New Zealand |
| Bowen Hospital | Wellington | 6035 | New Zealand |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | Posted | Count of Participants | Participants | Assessed 2 weeks after mask fitting |
|
|
|
| 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. | Posted | Count of Participants | Participants | Assessed 2 weeks after mask fitting |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 10 |
| 44 |
|
| Broken ankle | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated, resolved no sequel |
|
| Nasal compression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Related, ongoing at study end. |
|
| Knee pain | Injury, poisoning and procedural complications | Systematic Assessment | From previous surgery. Not related, resolved with sequel. |
|
| Left shoulder pain | Injury, poisoning and procedural complications | Systematic Assessment | After strain. Not related, ongoing at study end. |
|
| Nose bleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Possibly related, resolved no sequel |
|
| Eye irritation | Eye disorders | Systematic Assessment | Following up. |
|
| Mouth abscess | Psychiatric disorders | Systematic Assessment | Stress induced. Not related, resolved no sequel. |
|
| Mouth Ulcer | Gastrointestinal disorders | Systematic Assessment | Not related, ongoing at study end. |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|
|
| Very difficult |
|
| Title |
|---|
| Measurements |
|---|
|
| Very poor |
|