Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2023-11-27
2024-06-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-arm, non-randomised open-label
F&P Caramel
Nasal mask
Interventions
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F&P Caramel
Nasal mask
Eligibility Criteria
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Inclusion Criteria
* Persons who weigh ≥66 pounds
* Persons who have been prescribed PAP therapy by a physician
* Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
* Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
* Persons who are fluent in spoken and written English
* Persons who possess the capacity to provide informed consent
Exclusion Criteria
* Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps
* Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
* Persons who have an IPAP pressure of \>30 cmH2O if on BPAP
* Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
* Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site
22 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Locations
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Clayton Sleep Institute
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CIA-337
Identifier Type: -
Identifier Source: org_study_id
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