Noninvasive Blood Ethanol Measurement With Infrared Spectroscopy
Condition: Healthy Individuals; At Least 21 Years of Age
Study type: Observational

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

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.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
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 -