An Investigation to Test a Prototype Nasal Mask in the Home Setting
NCT ID: NCT03752580
Last Updated: 2019-01-24
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
20 participants
INTERVENTIONAL
2018-10-15
2018-10-19
Brief Summary
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Detailed Description
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Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm
Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.
User Instructions of novel nasal mask
User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).
Interventions
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User Instructions of novel nasal mask
User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).
Eligibility Criteria
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Inclusion Criteria
* 18+ years of age
* Ability to give informed consent
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Locations
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Fisher & Paykel Healthcare
Auckland, , New Zealand
Countries
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Other Identifiers
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CIA-240
Identifier Type: -
Identifier Source: org_study_id
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