Towards a Wearable Alcohol Biosensor: Examining the Accuracy of BAC Estimates From New-Generation Transdermal Technology Using Large-Scale Human Testing and Machine Learning Algorithms

January 19, 2023 updated by: Catharine Fairbairn, University of Illinois at Urbana-Champaign
The study will employ a combined laboratory-ambulatory design. Participants will engage in ambulatory assessment over the course of 14 days, wearing biosensors assessing transdermal alcohol concentration (TAC) and providing breathalyzer readings in real-world contexts. Also during this period, participants will attend three laboratory alcohol-administration sessions scheduled at one-week intervals, with alcohol dose and rate of consumption manipulated within and between participants, respectively. Laboratory visits will also double as ambulatory orientation, check-in, and close-out sessions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Laboratory Procedures: The aim of the laboratory study is to capture the effect of variable alcohol doses and rates of consumption on the TAC-BAC relationship across individuals in a controlled context. Laboratory alcohol-administration sessions will be held at one-week intervals, scheduled at study initiation (day 0), study midpoint (day 7), and study end (day 14).

Alcohol-administration procedures will employ a within (alcohol dose) X between (rate of consumption) participant design. All participants will consume three doses of alcohol over the course of the three laboratory sessions, targeting peak blood alcohol concentration (BAC) levels of .03%, .06%, and .09% respectively. The order of alcohol doses will be counterbalanced across participants. The exact quantity of alcohol administered to each participant in order to achieve these target peak BACs will be calculated based on individualized formulas adjusting for drinking rate, sex, height, weight, and age (see formulas provided in Watson et al., (1981)). Rate of consumption will be manipulated between participants, with equal numbers of participants assigned to consume alcohol at relatively "fast" and "slow" rates. Beverage intake will be monitored to ensure participant comfort and even consumption across the beverage administration period. After beverage administration, participants will provide breath alcohol concentration (BrAC) readings at 10- min intervals.

In addition, during the laboratory procedures, participants will be exposed to environmental factors that are known to impact the transdermal reading of the Skyn device. These manipulations will allow the research team to train the machine learning algorithm to recognize and model for these environmental effects. These manipulations include: 1) Environmental alcohol: common household products containing alcohol (e.g., hand sanitizer, perfume, lotion containing alcohol) will be sprayed or applied in proximity to Skyn; 2) Sweating: Participants will be asked to engage in a brief 10-30 minute aerobic exercise while in a seated position (i.e., stationary biking) while under the supervision of a research assistant. This brief exercise will be designed simply to yield exertion to the point of sweating and not exertion beyond this point; 3) Arm Movements: Participants will be asked to engage in isolated body movements (e.g., arms and feet) to determine whether device shifting caused by such movements impact readings taken by Skyn.

Ambulatory Procedures: This arm of the study aims to capture the TAC-BAC relationship among participants drinking in everyday settings. Ambulatory assessment will take place over 14 days. During laboratory session 1, prior to beverage administration, participants will be oriented to ambulatory study procedures. The Skyn device will be worn throughout participation. During orientation, participants will be trained to use the mobile breathalyzer. To avoid contamination of breathalyzer readings by mouth alcohol, participants will be instructed to wait 5 minutes after their last sip of alcohol to provide a reading. Also during this orientation session, participants will receive training in standard drink reporting (used to validate breathalyzer readings). During ambulatory assessment, participants will provide breathalyzer readings in response to both random and user-initiated prompts via their smartphones. On day 14 of the study, participants will attend a final laboratory session during which they will return study equipment as well as complete questionnaires asking them to reflect on their experience using the Skyn and their likelihood to adopt a Skyn application.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Recruiting
        • University of Illinois at Urbana-Champaign
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 years or older
  • drink alcohol at least 2x weekly

Exclusion Criteria:

  • psychological or medical conditions that might contraindicate alcohol-administration
  • history of adverse reaction to type and amount of beverage used in the study
  • currently seeking treatment for alcohol use disorder
  • does not drink alcohol regularly
  • taking drugs or medications for which alcohol consumption would be contraindicated
  • women who are pregnant or are attempting to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast Condition
Participants randomized to consume study beverages at a comparatively rapid rate.
Drug: Alcohol
Alcohol administered orally at multiple doses and consumption speeds to test transdermal device accuracy
Experimental: Slow Condition
Participants randomized to consume study beverages at a comparatively slow rate.
Drug: Alcohol
Alcohol administered orally at multiple doses and consumption speeds to test transdermal device accuracy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Breath Alcohol Concentration During Laboratory Visits
Time Frame: From beginning to end of alcohol administration visit, measured every ten minutes, up to 12 hours
change in alcohol concentration through breath provided in the laboratory
From beginning to end of alcohol administration visit, measured every ten minutes, up to 12 hours
Change in Ambulatory Breath Alcohol Concentration
Time Frame: up to 2 weeks
change in measure of alcohol concentration through breath provided in the field
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Catharine Fairbairn, PhD, University of Illinois Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2022

Primary Completion (Anticipated)

August 1, 2026

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA028488-01A1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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