Usability Study for SOBERLINK System

Completed · Not applicable

Conditions studied: Alcoholism, Alcohol Dependence

In brief

The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the end user in a simulated home use environment or by Rx in clinic. The patient labeling will be in the format intended for distribution. Ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device while an additional ten (10) Rx subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. An additional ten (10) simulated home use subjects will be provided instruction for use for the Soberlink Cellular device while an additional ten (10) simulated home use subjects will be provided instruction for use in clinic for the Soberlink Cellular device and Sober Sky web portal. All subjects will be provided with a post-test questionnaire on how to operate the device. The post-test questionnaire will collect information regarding device use. The device's use will be compared with identified risks to determine if the percentage of failures is within the study protocol success criteria. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Key facts

Study ID

NCT02650180

Run by

Soberlink Healthcare LLC

People needed

40

Starts

2015-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-03-09

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants between the ages of 18-99 years old in a clinical setting under the care of a healthcare provider.
• Male and female participants between the ages of 18-99 years old in an over-the-counter setting (home use setting).

You may not qualify if…

• Participants with lung disease unable to exhale for 4 seconds.

Where it is running

• Private Practice — Fullerton, California, United States
• Addiction Alternatives — Los Angeles, California, United States
• Hazelden Betty Ford — Center City, Minnesota, United States

Full record on ClinicalTrials.gov

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