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.
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.
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.
- Conditions
- Healthy Individuals, At Least 21 Years of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- InLight Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TruTouch Technologies
- Investigators
- Mark Rohrscheib, M.D., Principal investigator, UNMHSC
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Blood Ethanol Measurement With Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01168102
- Acronym / sponsor ID
- ILS-07-051
- Conditions
- Healthy Individuals, At Least 21 Years of Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- InLight SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- TruTouch Technologies
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: 1. Over the age of 21 but under the age of 70 2. No history of alcoholism -
Key inclusion criteria (2 listed)
- Over the age of 21 but under the age of 70
- No history of alcoholism -
Key exclusion criteria (5 listed)
- 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). -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Rohrscheib, M.D. principal investigator
UNMHSC
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.