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| Name | Class |
|---|---|
| North Texas Lung & Sleep Clinic | OTHER |
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This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database
Visit 1 will involve the participants being fitted with the F&P trial full face or nasal mask for use in-home.
The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F&P Seal Improvement Project | Experimental | participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F&P Seal Improvement Project | Device | Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Subjective Usability Reporting | Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home |
| Number or Participants Comparative Subjective Reported Comfort | Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual | 14 ± 4 days in-Home |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Performance Reporting | Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home |
| Number of Participants Reported Mask Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ostransky, MD | Board Certified Sleep Specialist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North texas Lung and Sleep Clinic | Fort Worth | Texas | 76109 | United States |
Investigation to inform product development team. Results will inform product development on the future of the product.
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| ID | Title | Description |
|---|---|---|
| FG000 | F&P Seal Improvement Project | participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | F&P Seal Improvement Project | participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or 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, 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 | Number of Participants Subjective Usability Reporting | Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 4 days in-Home |
|
|
1 year
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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 Seal Improvement Project | F&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or 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 | Apr 12, 2017 | Jun 24, 2021 | Prot_SAP_001.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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Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea |
| 14 ± 4 days in-Home |
| Number of Participants Subjective Comfort Reporting | Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home |
| Number or Participants Subjective Reporting of Seal Performance | Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | 14 ± 4 days in-Home |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number or Participants Comparative Subjective Reported Comfort | Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual | Posted | Count of Participants | Participants | 14 ± 4 days in-Home |
|
|
|
| Secondary | Objective Performance Reporting | Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 4 days in-Home |
|
|
|
| Secondary | Number of Participants Reported Mask Acceptability | Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 4 days in-Home |
|
|
|
| Secondary | Number of Participants Subjective Comfort Reporting | Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 4 days in-Home |
|
|
|
| Secondary | Number or Participants Subjective Reporting of Seal Performance | Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea | Posted | Count of Participants | Participants | 14 ± 4 days in-Home |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Not collected |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Uncomfortable |
|
| Very uncomfortable |
|
| Title | Measurements |
|---|---|
|
| Poor |
|
| Very poor |
|