Accuracy & Usability Study for Soberlin… | Clinical Trial

Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 alcohol and use the Soberlink Cellular Device to measure their blood alcohol content (BAC) in comparison to a predicate device.

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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Soberlink Cellular Device

Device

BAC breath analyzer

BACtrack S80 Pro

Device

BAC breath analyzer

Primary outcomes

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

Time frame: Day 1

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.

Secondary outcomes

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

Time frame: Day 1

Performance validation will occur by evaluating the usability of the Soberlink Cellular device in the hand of intended users - untrained study participants who have consumed alcohol and used the device to measure their blood alcohol content (BAC). 40 adults who have recently consumed alcohol will be asked to evaluate the Soberlink Cellular device. The only assistance 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 should be taken within 5 minutes of the first. Following the second measurement a questionnaire will be administered to study participants to evaluate the ease of use of the Soberlink Cellular device.

Sponsors and collaborators

Lead sponsor

Soberlink Healthcare LLC

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jun 8, 2016
Registry last updated: Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed