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Healthy IndividualsNCT01168102

Noninvasive Blood Ethanol Measurement With Infrared Spectroscopy

An observational study of Healthy Individuals and At Least 21 Years of Age, run by InLight Solutions at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the performance of a noninvasive device for the detection of blood alcohol levels. Read more about this study

Who is it for?
Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Individuals, At Least 21 Years of Age
How many people
500 participants
Where
1 siteUnited States
Study dates
Mar 2007to Dec 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Inclusion Criteria: 1. Over the age of 21 but under the age of 70 2. No history of alcoholism -

Who may be able to join

  • Over the age of 21 but under the age of 70
  • No history of alcoholism -

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • InLight Solutions

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

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

Read the 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2010 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01168102
Sponsor's protocol ID
ILS-07-051
Status last verified
Feb 2008
First submitted
21 Jul 2010
Last updated
22 Jul 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Individuals and At Least 21 Years of Age, run by InLight Solutions at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2010.

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