Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT02297789
Last Updated: 2015-07-24
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
11 participants
INTERVENTIONAL
2014-11-30
2014-12-31
Brief Summary
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The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Headgear 1
Full Face Mask with Headgear 1
Investigative Full Face Mask with Headgear
Headgear 2
Full Face Mask with Headgear 2
Investigative Full Face Mask with Headgear
Interventions
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Investigative Full Face Mask with Headgear
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years of age
* Either prescribed APAP or CPAP or Bi level for OSA
* Existing full face users
Exclusion Criteria
* Participant intolerance to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* Current diagnosis of respiratory disease or CO2 retention
* Pregnant or think they may be pregnant
18 Years
ALL
Yes
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Bhavi Ogra, BSc
Role: PRINCIPAL_INVESTIGATOR
Fisher & Paykel Healthcare
Locations
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Fisher & Paykel Healthcare Ltd.
Auckland, East Tamaki, New Zealand
Countries
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Other Identifiers
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CIA-152
Identifier Type: -
Identifier Source: org_study_id
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