Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
70 participants
OBSERVATIONAL
2022-11-10
2023-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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In-House Usability Study Group
Seventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night.
Participants will follow instructions to set up and put on the Eclipse nasal mask.
They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
Eclipse mask
Users will interact with the Eclipse CPAP machine and report on usability/likeability.
Interventions
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Eclipse mask
Users will interact with the Eclipse CPAP machine and report on usability/likeability.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Under the age of 18: target for this current version of the platform is the adult population.
18 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Bleep, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Stuart Heatherington
Role: PRINCIPAL_INVESTIGATOR
Bleep, LLC
Locations
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AeroFlow Sleep
Asheville, North Carolina, United States
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, United States
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, 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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BSL-SNAP-002
Identifier Type: -
Identifier Source: org_study_id