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This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited
This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.
The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F&P Saturn | Experimental | Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F&P Saturn | Device | Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Comfort Compared to Their Usual Mask. | Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home |
| Number of Participants PAP Device Performance Reporting | Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home |
| Number of Participants Subjective Performance Rating of the Nasal Mask | Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home |
| Number of Participants Subjective Reporting of Nasal Mask Usability | Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | During Visit Two - 20 minutes |
| Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Leak Compared to Usual Mask | Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | 14 ± 5 days In-Home |
| Number of Participants With Correct Nasal Mask Size Determination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials of Florida | South Miami | Florida | 33186 | United States |
Data will not be shared with any other researchers or parties.
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| ID | Title | Description |
|---|---|---|
| FG000 | F&P Nasal Mask | Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | F&P Nasal | Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal 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, 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 | Number of Participants Reporting Comfort Compared to Their Usual Mask. | Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
2 weeks
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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 Nasal Mask | Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hanie Yee | Fisher & Paykel Healthcare | +64 9 574 0123 | 7909 | Hanie.Yee@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 | Mar 12, 2017 | Jun 24, 2021 | Prot_SAP_002.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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After a period of baseline, all enrolled participants will be put on the same trial mask.
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Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea |
| 1 day-time appointment (1 hour) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants PAP Device Performance Reporting | Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Primary | Number of Participants Subjective Performance Rating of the Nasal Mask | Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Primary | Number of Participants Subjective Reporting of Nasal Mask Usability | Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | During Visit Two - 20 minutes |
|
|
|
| Primary | Number of Participants Subjective Recording of Ease of Nasal Mask Use. | Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Secondary | Number of Participants Leak Compared to Usual Mask | Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Secondary | Number of Participants With Correct Nasal Mask Size Determination | Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 1 day-time appointment (1 hour) |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Measurements |
|---|
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| No data |
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| Poor |
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| Very Poor |
|
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| Difficult |
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| Very Difficult |
|
|
| Difficult |
|
| Very Difficult |
|
| Worse than current mask |
|
|