Status:
COMPLETED
Accuracy & Usability Study for Soberlink Cellular Device
Lead Sponsor:
Soberlink Healthcare LLC
Conditions:
Substance Abuse
Eligibility:
All Genders
21-99 years
Phase:
NA
Brief Summary
This study scope is to validate the accuracy and usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro.
Detailed Description
The purpose of this accuracy and usability study is to validate the performance of Soberlink Cellular Device in the hands of the intended (lay) users - untrained study participants who have consumed a...
Eligibility Criteria
Inclusion
- Subject willing to sign an informed consent
- 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
- Subject with previous Alcohol Breathalyzer experience
- 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
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02794038
Start Date
June 1 2016
End Date
June 1 2016
Last Update
June 10 2016
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