Usability Study for SOBERLINK System
Launched by SOBERLINK HEALTHCARE LLC · Jan 7, 2016
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
Forty (40) subjects identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Subjects will be asked to sign informed consent. The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the patient in a simulated home-use environment and Rx clinical setting. 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...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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).
- Exclusion Criteria:
- • Participants with lung disease unable to exhale for 4 seconds.
About Soberlink Healthcare Llc
Soberlink Healthcare LLC is a leading provider of innovative technology solutions designed to support individuals in their recovery from substance use disorders. Specializing in remote alcohol monitoring, Soberlink combines advanced breathalyzer devices with cloud-based reporting to facilitate real-time data sharing with healthcare providers, family members, and support networks. Committed to enhancing accountability and promoting positive behavioral changes, Soberlink is dedicated to improving patient outcomes through its evidence-based approach and robust clinical research initiatives. The company aims to empower users on their recovery journey while fostering a collaborative environment among caregivers and loved ones.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fullerton, California, United States
Los Angeles, California, United States
Center City, Minnesota, United States
Patients applied
Trial Officials
Jenna Costa, BA
Study Director
Soberlink Healthcare LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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