Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).
The participant then will come in to return the mask (Visit Three) and give their 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 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 their Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F&P Toffee mask | Experimental | Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F&P Toffee mask | Device | Trial Full-Face mask which comes with three seal sizes and two headgear sizes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trial Mask Comfort | Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective | 14 ± 5 days In-Home |
| Trial Mask Performance - Objective | Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective | 14 ± 5 days In-Home |
| Trial Mask Performance - Subjective | Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective | 14 ± 5 days In-Home |
| Trial Mask Usability | Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective | During Visit Two - 20 minutes |
| Trial Mask Ease-of-Use | Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective | 14 ± 5 days In-Home |
| Measure | Description | Time Frame |
|---|---|---|
| Mask Leak Data | Leak data recorded from PAP device - Objective | 14 ± 5 days In-Home |
| Seal Size Determination | Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Sleep Solutions | Roseville | California | 95661 | United States |
Individual participant data will not be available to other researchers or institutions. Identifiable participant data will not leave the site and all other data will be de-identified.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | F&P Toffee Mask | Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | F&P Toffee Mask | Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes. |
| 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 Comfort | Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.
Not provided
Not provided
| 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 Toffee Mask | Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. F&P Toffee mask: Trial Full-Face mask which comes with three seal sizes and two headgear sizes. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal congestion and sore | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Facial pressure sore on bridge of nose, sinus infection |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Thomson | Fisher & Paykel Healthcare Ltd. | +64 9 574 0123 | 7675 | Rebecca.Thomson@fphcare.co.nz |
Not provided
| 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 | Sep 6, 2017 | May 25, 2022 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
After a period of baseline, all enrolled participants will be put on the same trial mask.
Not provided
Not provided
Not provided
Not provided
| 1 day-time appointment (1 hour) during Visit Two |
| Efficacy Data | AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective | 14 ± 5 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 |
|
|
| Primary | Trial Mask Performance - Objective | Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Primary | Trial Mask Performance - Subjective | Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Primary | Trial Mask Usability | Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective | Posted | Count of Participants | Participants | During Visit Two - 20 minutes |
|
|
|
| Primary | Trial Mask Ease-of-Use | Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Secondary | Mask Leak Data | Leak data recorded from PAP device - Objective | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| Secondary | Seal Size Determination | Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant. | Posted | Count of Participants | Participants | 1 day-time appointment (1 hour) during Visit Two |
|
|
|
| Secondary | Efficacy Data | AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective | Posted | Count of Participants | Participants | 14 ± 5 days In-Home |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 2 |
| 38 |
|
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title |
|---|
| Measurements |
|---|
|
| N/A |
|
|
| Worse |
|
| Much worse |
|
| Title | Measurements |
|---|
|
|
| Worse |
|
| Much worse |
|
| No data |
|
| Measurements |
|---|
|
| No data |
|