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Accuracy & Usability Study for Soberlink Cellular Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794038
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Soberlink Healthcare LLC

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Device: Soberlink Cellular Device Device: BACtrack S80 Pro Not Applicable

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 This accuracy and usability study will be performed on Soberlink Cellular Device in order to comply with FDA's Draft Guidance for Industry and Food and Drug Administration Staff, titled: Applying Human Factors and Usability Engineering to Optimize Medical Device Design, IEC 60601-1-6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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Accuracy & Usability Study for Soberlink Cellular Device
Study Start Date : June 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Active Comparator: Soberlink Cellular Device
BAC reading with Soberlink Cellular Device
Device: BACtrack S80 Pro
BAC breath analyzer

Active Comparator: BACtrack S80 Pro
BAC reading with BACtrack S80 Pro
Device: Soberlink Cellular Device
BAC breath analyzer




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794038


Sponsors and Collaborators
Soberlink Healthcare LLC
Investigators
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Principal Investigator: Shannon Hanrahan, PhD Private Practice
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Responsible Party: Soberlink Healthcare LLC
ClinicalTrials.gov Identifier: NCT02794038    
Other Study ID Numbers: ACUSPROT 2016-001
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant will be aware of their own BAC result as the result is displayed on the LED screen of the device
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders