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The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.
The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.
The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alternative sizing model trial mask | Experimental | In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm. |
|
| Prototype Full Face Mask (PFFM) | Active Comparator | In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternative sizing model based trial mask | Device | A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seal Comfort | Obtained from subjective questionnaire | Up to 3 weeks in-home |
| Subjective Seal Leak | Obtained from subjective questionnaire | Up to 3 weeks in-home |
| Objective Seal Leak | Measured by device data | Up to 3 weeks in-home |
| Measure | Description | Time Frame |
|---|---|---|
| Objective correct mask selection | Measured by device leak data | Up to 3 weeks in-home |
| Subjective correct mask selection | Measured by subjective questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kayan Gonda, BSc | Sponsor Employee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hastings Memorial Hospital | Hastings | Hawkes Bay | 1420 | New Zealand | ||
| Waikato Hospital (Waikato DHB) |
This is a pilot investigation from which data will be used to inform product development on future projects and investigations.
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| Prototype Full Face Mask | Device | A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy. |
|
| Up to 3 weeks in-home |
| Hamilton |
| Waikato Region |
| 3204 |
| New Zealand |
| Fisher & Paykel Healthcare | Auckland | 2013 | New Zealand |
| Bowen Hospital | Wellington | 6035 | New Zealand |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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