The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT03413098
Last Updated: 2018-03-22
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
30 participants
INTERVENTIONAL
2018-02-12
2018-03-09
Brief Summary
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Detailed Description
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The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Trial nasal Continuous Positive Airway Pressure (CPAP) mask
Trial nasal CPAP mask
Nasal CPAP mask
Investigative Nasal Mask to be used for OSA therapy
Interventions
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Nasal CPAP mask
Investigative Nasal 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 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
Sponsor Employee
Locations
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Hastings Memorial Hospital
Hastings, , New Zealand
WellSleep
Wellington, , New Zealand
Countries
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Other Identifiers
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CIA233
Identifier Type: -
Identifier Source: org_study_id
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