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This clinical investigation is designed to assess the F&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery.
The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.
This clinical investigation is designed to assess the F&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F&P Toffee Nasal or Toffee Nasal Pillows mask.
The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F&P Toffee Nasal and Toffee Nasal Pillows Mask | Experimental | Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F&P Toffee Nasal and Toffee Nasal Pillows Masks | Device | F&P Toffee Nasal and Toffee Nasal Pillows Masks are intended to be used within the traditional PAP therapy system and are designed to facilitate equivalent PAP therapeutic efficacy as defined by standard practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Efficacy | The F&P Toffee Nasal and Toffee Nasal Pillows masks provides adequate PAP therapy when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines after 14 days of use. | After two weeks of use |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | The F&P Toffee Nasal and Toffee Nasal Pillows is comfortable during PAP therapy when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire after 14 days of use. | After two weeks of use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site Partners, LLC - DBA CSP Miami | Miami | Florida | 33186 | United States | ||
| Clayton Sleep Institute |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 28, 2025 | Jun 11, 2025 | 5 | ||
| Jul 15, 2025 |
| 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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| St Louis |
| Missouri |
| 63123 |
| United States |
| Jul 31, 2025 |
| 6 |
| Aug 14, 2025 | Sep 2, 2025 | 7 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |