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Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.
The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Headgear 1 | Experimental | Full Face Mask with Headgear 1 |
|
| Headgear 2 | Experimental | Full Face Mask with Headgear 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigative Full Face Mask with Headgear | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mask is comfortable and is effective for the participant during in-home use | Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data. | 1 week for each mask prototype in-home |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Full Face mask prototypes | Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log | 1 week for each mask prototype in-home |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhavi Ogra, BSc | Fisher & Paykel Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisher & Paykel Healthcare Ltd. | Auckland | East Tamaki | 1010 | New Zealand |
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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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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |