Accuracy & Usability Study for Soberlink Cellular Device

NCT02794038 | Completed

• 1 other identifier: ACUSPROT 2016-001
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (1)

• Validate the accuracy of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by linear regression.

  Performance validation will occur by evaluating the accuracy of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and use the device to measure their blood alcohol content (BAC). 40 adults will be recruited who have recently consumed alcohol. The only assistance to be provided is the labeling. No additional coaching, either written or verbal, will be provided to study participants. Participants should obtain a BAC reading with the Soberlink Cellular device, and a second BAC reading with a comparator device. The second measurement will be taken within 5 minutes of the first. A linear regression line for the comparison between results of the Soberlink Cellular device and a comparator will be made.

  Day 1

Secondary Outcomes (1)

• Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.

  Day 1

Study Arms (2)

Soberlink Cellular Device

ACTIVE COMPARATOR

BAC reading with Soberlink Cellular Device

Device: BACtrack S80 Pro

BACtrack S80 Pro

ACTIVE COMPARATOR

BAC reading with BACtrack S80 Pro

Device: Soberlink Cellular Device

Interventions

Soberlink Cellular Device DEVICE

BAC breath analyzer

BACtrack S80 Pro

BACtrack S80 Pro DEVICE

BAC breath analyzer

Soberlink Cellular Device

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soberlink Healthcare LLC: lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Shannon Hanrahan, PhD

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 8, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share