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The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm, non-randomised open-label | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F&P Caramel | Device | Nasal mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Efficacy | Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score. | Baseline and14±5 days |
| Epworth Sleepiness Scale | All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes) | Baseline and14±5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clayton Sleep Institute | St Louis | Missouri | 63123 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caramel Nasal Mask | Participants to use nasal mask for 14 days. Caramel Nasal Mask:Nasl mask for the treatment of obstructive sleep apnea (OSA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants with obstructive sleep apnea (OSA) that have been been prescribed positive airway pressure (PAP) therapy
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| ID | Title | Description |
|---|---|---|
| BG000 | F&P Caramel: Nasal Mask | Participants to use nasal mask for 14 days. Caramel Nasal Mask: Nasal 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 | Therapeutic Efficacy | Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score. | Posted | Mean | Full Range | events per hour | Baseline and14±5 days |
|
14 days
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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 | F&P Caramel: Nasal Mask | Participants to use nasal mask for 14 days. Caramel Nasal Mask: Nasal mask for the treatment of obstructive sleep apnea (OSA). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Tay | Fisher & Paykel Healthcare Ltd | +64 9-282-9734 | 5634 | kelly.tay@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 18, 2023 | Jul 14, 2025 | 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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Epworth Sleepiness Scale | All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes) | Posted | Mean | Full Range | Epworth Sleepiness Score (ESS) | Baseline and14±5 days |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 4 |
| 43 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |