Accuracy & Usability Study for Soberlink Cellular Device

Substance Abuse Clinical Trial

Official title:

Accuracy & Usability Study for Soberlink Cellular Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794038
• Other study ID #: ACUSPROT 2016-001
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 9, 2016
• Start date: June 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Soberlink Healthcare LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

Device:
• Soberlink Cellular Device
BAC breath analyzer
• BACtrack S80 Pro
BAC breath analyzer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soberlink Healthcare LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Validate the usability of the Soberlink Cellular Device in comparison to a predicate device, BACtrack S80 Pro and assessed by Questionnaire.	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.	Day 1