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This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.
A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will undergo an overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab.
The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Nasal Pillows Mask | Experimental | Participants to use nasal pillows mask one night in lab overnight polysomnography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New Nasal Pillows Mask | Device | Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask | 12 hours | |
| Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhavi Ogra, BSc | Sponsor Employee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare Ltd | Auckland | East Tamaki | 2013 | New Zealand |
For product development purposes only. Data will be de-identified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toffee Nasal Pillows Mask | Participants to use nasal pillows mask one night in lab overnight polysomnography. New Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toffee Nasal Pillows Mask | Participants to use nasal pillows mask one night in lab overnight polysomnography. Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA) |
| 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 | Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks | Posted | Count of Participants | Participants | 12 hours |
|
|
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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 to use nasal pillows mask one night in lab overnight polysomnography. Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Lambert | Fisher & Paykel Healthcare Ltd. | +64 9 574 0123 | 7172 | christine.lambert@fphcare.co.nz |
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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 |
|
|
| Secondary | Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask | Posted | Count of Participants | Participants | 12 hours |
|
|
|
| Secondary | Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask | Posted | Count of Participants | Participants | 12 hours |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |