Accuracy & Usability Study for Soberlink Cellular Device
NCT ID: NCT02794038
Last Updated: 2016-06-10
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
43 participants
INTERVENTIONAL
2016-06-30
2016-06-30
Brief Summary
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Detailed Description
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The purpose of this document is to define how the human factors environment impacts the actual user interface design as well as how usability engineering evaluates user interface via usability objectives and usability tests. This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6 (collateral standard for usability engineering of medical electrical equipment), and IEC 62366 (application of usability engineering to medical devices).
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
NONE
Study Groups
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Soberlink Cellular Device
BAC reading with Soberlink Cellular Device
BACtrack S80 Pro
BAC breath analyzer
BACtrack S80 Pro
BAC reading with BACtrack S80 Pro
Soberlink Cellular Device
BAC breath analyzer
Interventions
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Soberlink Cellular Device
BAC breath analyzer
BACtrack S80 Pro
BAC breath analyzer
Eligibility Criteria
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Inclusion Criteria
* Male or female subject between the ages of 21-99 years old
* Untrained subject in the use of an Alcohol Breathalyzer
* Subject willing to consume two alcoholic drinks
* Subjects willing to use two Alcohol Breathalyzers
* Subject willing to complete a Questionnaire
Exclusion Criteria
* Subject currently in substance use rehabilitation or post rehabilitation, or unauthorized to consume alcohol for any other reason
* Subject with lung disease, or is physically unable to provide a deep lung exhalation for 4 seconds
* Subject unwilling to drink two alcoholic drinks
* Subject unwilling to complete a questionnaire
* Subject that is non-English speaking
* Subject that is a child, adolescent, or cognitively impaired.
* Subject that is a pregnant and/or breastfeeding woman
21 Years
99 Years
ALL
Yes
Sponsors
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Soberlink Healthcare LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Shannon Hanrahan, PhD
Role: PRINCIPAL_INVESTIGATOR
Private Practice
Other Identifiers
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ACUSPROT 2016-001
Identifier Type: -
Identifier Source: org_study_id
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