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This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F&P Toffee mask for use in home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 2 weeks of the beginning of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toffee Full Face Mask | Experimental | Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toffee Full Face Mask | Device | Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Toffee Mask Acceptability | Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective | 14±4 days in home |
| Toffee Mask Comfort | Overall Toffee mask comfort determined from questionnaires-Subjective | 14±4 days in home |
| Toffee Mask Treatment Seal Performance-Subjective | Sealing performance of Toffee mask determined from questionnaires - Subjective | 14±4 days in home |
| Measure | Description | Time Frame |
|---|---|---|
| Toffee Mask Treatment Performance-Objective | Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective | 14±4 days in home |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Goodwin | Research Director | Study Director |
| Thomas O'Brien, MD | Pulmonologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Disease Specialists | Orlando | Florida | 34741 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Toffee Full Face Mask | Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toffee Full Face Mask | Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. |
| 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 | Toffee Mask Acceptability | Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective | Posted | Count of Participants | Participants | 14±4 days in home |
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Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.
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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 | Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cheek pressure/ discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Cheek pressure/ discomfort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bhavi Ogra | Fisher & Paykel Healthcare Ltd. | +64 9 574 0123 | 7675 | 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 | Oct 12, 2018 | May 25, 2022 | Prot_SAP_001.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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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|
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| Primary | Toffee Mask Comfort | Overall Toffee mask comfort determined from questionnaires-Subjective | Posted | Count of Participants | Participants | 14±4 days in home |
|
|
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| Primary | Toffee Mask Treatment Seal Performance-Subjective | Sealing performance of Toffee mask determined from questionnaires - Subjective | Posted | Count of Participants | Participants | 14±4 days in home |
|
|
|
| Secondary | Toffee Mask Treatment Performance-Objective | Objective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective | Posted | Count of Participants | Participants | 14±4 days in home |
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|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 4 |
| 39 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|
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| Uncomfortable |
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| Very uncomfortable |
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| Title | Measurements |
|---|---|
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| Poor |
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| Very poor |
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| Title | Measurements |
|---|---|
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