Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
NCT ID: NCT05570747
Last Updated: 2025-11-10
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
35 participants
OBSERVATIONAL
2022-10-19
2022-11-11
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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traditional CPAP Nuance mask users
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Usability
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
DreamPort-Eclipse mask users
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Usability
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
Interventions
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Usability
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
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-001
Identifier Type: -
Identifier Source: org_study_id