The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT03230877
Last Updated: 2022-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
38 participants
INTERVENTIONAL
2017-09-02
2017-11-30
Brief Summary
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Detailed Description
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The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.
Visit Three will involve the participants returning the second trial seal and providing feedback.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Group A
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Toffee full face mask with 'Improved Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
Toffee full face mask with 'Normal Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
Group B
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
Toffee full face mask with 'Improved Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
Toffee full face mask with 'Normal Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
Interventions
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Toffee full face mask with 'Improved Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
Toffee full face mask with 'Normal Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent
* Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
* Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
* Fluent in spoken and written English
* Existing F\&P full face mask user
Exclusion Criteria
* Participant intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
* Pregnant or may think they are pregnant.
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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Clinical Trials of Florida
Miami, Florida, 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-223
Identifier Type: -
Identifier Source: org_study_id
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