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The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site
This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.
The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.
Visit Three will involve the participants returning the second trial seal and providing feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2. |
|
| Group B | Experimental | Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toffee full face mask with 'Improved Seal' | Device | Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Trial Mask Seal Comfort | Overall seal comfort determined from questionnaires- Subjective | 7 ± 4 days in-home |
| Trial Mask Seal Acceptability | Preference for trial mask determined from questionnaires at the end of the trial - Subjective | 14 ± 4 days in-home |
| Measure | Description | Time Frame |
|---|---|---|
| Trial Mask Seal Treatment Performance - Objective | Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data | 7 ± 4 days in-home |
| Trial Mask Seal Usability |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials of Florida | Miami | Florida | 33186 | United States |
This investigation is to inform product development team. Results will inform product development on the future of the product.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Seal Then Improved Seal | Participants will be randomized to the Normal Seal arm for a total of 7 ± 4 days from visit 1 and then will be crossed over to the Improved Seal arm for a total of 7 ± 4 days from visit 2. |
| FG001 | Improved Seal Then Normal Seal | Participants will be randomized to the Improved Seal arm for a total of 7 ± 4 days from visit 1 and then will be crossed over to the Normal Seal arm for a total of 7 ± 4 days from visit 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
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| Visit 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population | Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other 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 | Trial Mask Seal Comfort | Overall seal comfort determined from questionnaires- Subjective | Posted | Count of Participants | Participants | 7 ± 4 days in-home |
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Adverse events were collected for all participants during the 2 month study period.
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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 With 'Improved Seal' | Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm. Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Gunson | Fisher & Paykel Healthcare Ltd. | +64 9 574 0123 | 7675 | sarah.gunson@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 | Jul 28, 2017 | May 26, 2022 | 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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| Toffee full face mask with 'Normal Seal' | Device | Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm. |
|
Usability interview during first visit- Subjective
| 1 hour day-time appointment |
| Trial Mask Seal Treatment Performance- Subjective | Seal performance determined from questionnaires - Subjective | 7 ± 4 days in-home |
| NOT COMPLETED |
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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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| Primary | Trial Mask Seal Acceptability | Preference for trial mask determined from questionnaires at the end of the trial - Subjective | Posted | Count of Participants | Participants | 14 ± 4 days in-home |
|
|
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| Secondary | Trial Mask Seal Treatment Performance - Objective | Objective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data | Posted | Count of Participants | Participants | 7 ± 4 days in-home |
|
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| Secondary | Trial Mask Seal Usability | Usability interview during first visit- Subjective | Posted | Count of Participants | Participants | 1 hour day-time appointment |
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| Secondary | Trial Mask Seal Treatment Performance- Subjective | Seal performance determined from questionnaires - Subjective | Posted | Count of Participants | Participants | 7 ± 4 days in-home |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Toffee Full Face Mask With 'Normal Seal' | Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm. Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm. | 0 | 38 | 0 | 38 | 0 | 38 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| N/A |
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| Decreased AHI |
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| N/A |
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| Neither easy nor difficult |
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| Difficult |
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| Very difficult |
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| N/A |
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| Neither good nor poor |
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| Poor |
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| Very poor |
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| N/A |
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