Noninvasive Blood Ethanol Measurement With Infrared Spectroscopy

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. Identifier: NCT01168102
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : July 22, 2010
TruTouch Technologies
Information provided by:
InLight Solutions

Brief Summary:
The objective of this study is to assess the performance of a noninvasive device for the detection of blood alcohol levels.

Condition or disease
Healthy Individuals At Least 21 Years of Age

Detailed Description:

The use and abuse of alcohol in the workplace, on our highways, and in public places is a significant national problem that affects and puts at risk almost all Americans. Alcohol-related accidents, crimes, and incidents continue to rise in the United States and across the world. Each year, alcohol-associated fatalities, injuries, and property losses cost our nation billions of dollars in medical and insurance costs, lost wages and productivity. Current technology for detecting and screening alcohol use and impairment, both at the workplace and while operating a vehicle, raises a number of concerns related to its accuracy, ease of use, and reliability in the field. This technology offers a low-cost, non-invasive method by which to measure blood alcohol. The device does not rely on human fluids and is coupled with the ability to verify identity. This will be greatly preferable to current standards, which require lengthy procedures and costly disposables.

InLight Solutions and TruTouch Technologies are developing a compact, robust alcohol sensor derived from a miniature home glucose meter. Initial conceptual testing, using synthetic data, demonstrates a system with better than 0.01% BAC error without requiring costly disposables or exposing the test administrator to any biohazards. The system offers the potential for untrained or minimally trained operators to achieve clinically and legally accurate measurements in less than 30 seconds. Additionally, an autonomous instrument could be configured to allow identification and monitoring of alcohol offenders without any further judicial involvement.

InLight Solutions technology employs advanced optical tissue sampling techniques and sophisticated multivariate analysis techniques (also known as "chemometrics") for quantitative near-infrared spectroscopy. These optical measurement techniques employ the painless use of light directed through human tissue to measure the chemical constituency of blood and tissue. These techniques can measure a variety of blood analytes, including alcohol.

An additional capability of the device is to be able to identify subjects based upon their unique skin spectra. This capability could be used when the technology is used as an ignition interlock device. Currently, a breath alcohol detection device is used to start an ignition interlock. This poses a problem due to the fact that users are able to have a different "sober" person blow into the device. Our technology could bypass this problem by using the device to both identify the user and their current blood alcohol level.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Noninvasive Blood Ethanol Measurement With Infrared Spectroscopy
Study Start Date : March 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

  1. Over the age of 21 but under the age of 70
  2. No history of alcoholism -

Inclusion Criteria:

  1. Over the age of 21 but under the age of 70
  2. No history of alcoholism -

Exclusion Criteria:

  1. Pregnancy (Determined by Sure-Vue urine pregnancy test).
  2. Females that have given birth within 1 month prior or are currently breastfeeding.
  3. History of Alcoholism (Determined by MAST Test).
  4. Under the age of 21 (All Subjects will have ID Checked).
  5. Diagnosed with Type I or II Diabetes (Self-Reported). -

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 identifier (NCT number): NCT01168102

United States, New Mexico
InLight Solutions
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
InLight Solutions
TruTouch Technologies
Principal Investigator: Mark Rohrscheib, M.D. UNMHSC

Additional Information:
Responsible Party: Jeff Way, InLight Solutions Identifier: NCT01168102     History of Changes
Other Study ID Numbers: ILS-07-051
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: February 2008

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs