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| Name | Class |
|---|---|
| Aspen Clinical Research | OTHER |
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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 nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F&P Toffee nasal pillows 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 1 week of the beginning of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toffee Nasal Pillows Mask | Experimental | Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toffee Nasal Pillows Mask | Device | Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Toffee Mask Usability | Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult. | 14 ± 5 days in-Home |
| Toffee Mask Comfort | Determine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor | 14 ± 5 days in-Home |
| Toffee Mask Treatment Performance - Subjective | Determined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor | 14 ± 5 days in-Home |
| Trial Mask Acceptability | Participant count regarding whether they would continue using the trial mask if given the choice. | 14 ± 5 days in-Home |
| Measure | Description | Time Frame |
|---|---|---|
| Toffee Mask Treatment Performance - Objective | Objective data recorded from PAP device - Objective Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a "pass" or "fail" based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asim Roy | Board Certified Sleep Specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio Sleep Medicine Institute | Dublin | Ohio | 43017 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Toffee Nasal Pillows Mask | Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toffee Nasal Pillows Mask | Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows 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, Customized | 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 Usability | Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult. | Posted | Count of Participants | Participants | 14 ± 5 days in-Home |
|
|
Adverse events were 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 Nasal Pillows Mask | Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher and Paykel Healthcare | +64 09 574 0123 | 7044 | CPAP.trial@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 | Sep 1, 2017 | May 27, 2021 | 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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| 14 ± 5 days in-Home |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Toffee Mask Comfort | Determine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor | Posted | Count of Participants | Participants | 14 ± 5 days in-Home |
|
|
|
| Primary | Toffee Mask Treatment Performance - Subjective | Determined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor | Posted | Count of Participants | Participants | 14 ± 5 days in-Home |
|
|
|
| Primary | Trial Mask Acceptability | Participant count regarding whether they would continue using the trial mask if given the choice. | Posted | Count of Participants | Participants | 14 ± 5 days in-Home |
|
|
|
| Secondary | Toffee Mask Treatment Performance - Objective | Objective data recorded from PAP device - Objective Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a "pass" or "fail" based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail. | 4 data sets were unavailable for analysis | Posted | Count of Participants | Participants | 14 ± 5 days in-Home |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 8 |
| 38 |
| Sore on the top of the head | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |