The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
NCT ID: NCT03092921
Last Updated: 2017-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2017-03-27
2017-08-03
Brief Summary
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Detailed Description
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An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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F&P Mask Seal
Participants to use trial seal in-home for 1 week
F&P Mask Seal
Investigative Mask Seal to be used for OSA therapy
F&P Mask
Participants to use trial mask in-home for 2 weeks
F&P Mask
Investigative Mask to be used for OSA therapy
Interventions
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F&P Mask Seal
Investigative Mask Seal to be used for OSA therapy
F&P Mask
Investigative Mask to be used for OSA therapy
Eligibility Criteria
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Inclusion Criteria
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing oro-nasal mask user
Exclusion Criteria
* Patients who are in a coma or a decreased level of consciousness
* Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant
18 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Gunson
Role: PRINCIPAL_INVESTIGATOR
Employee
Locations
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Fisher & Paykel Healthcare
Auckland, , New Zealand
Countries
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Other Identifiers
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CIA-209
Identifier Type: -
Identifier Source: org_study_id
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