Calibration Study of a Blood Alcohol Level Smart Watch
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|ClinicalTrials.gov Identifier: NCT03574181|
Recruitment Status : Terminated (Extensive changes to the watch design would be needed to produce a robust device.)
First Posted : June 29, 2018
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment|
|Alcohol Drinking||Other: Smart watch to measure Blood Alcohol Level|
In this proposed study, the objective is to further demonstrate the reliability of this printed electrochemical gas sensor in the form of a wearable device. This demonstration of reliability among human subjects is an essential part of product development. The monitor will be in a wristband or watch form, similar to a smart watch. This device will be modern, attractive and comfortable. It will also have smart watch features including measuring key physiological parameters (e.g., pulse) and eventually will have connectivity to apps on smart phones and other devices. The aim of the work is to provide a new, noninvasive transdermal alcohol monitor into the market. The transdermal alcohol monitoring market has few wearable products available and innovation has been lacking in this field. This new product will take advantage of current trends in wearable technology. As the public becomes more comfortable with wearable sensors, the blood alcohol monitor will become popular with people interested in health and fitness who want to track their alcohol intake. The product will provide a new, highly reliable and sensitive method for tracking blood alcohol level. This may be particularly beneficial to individuals who seek to reduce the risk of alcohol use by limiting peak blood alcohol level. If successful, this technology could be adopted in many areas including clinical and medical treatment, employee wellness programs, alcohol clinical trials, and as part of brief interventions that target at-risk drinkers.
The specific objective of this study is to determine whether the printed electrochemical gas sensor designed to measure blood alcohol level will be sensitive and reliable when compared to a standard measure of blood alcohol level taken by a breathalyzer. If this sensor proves sensitive to changes in blood alcohol level and can reliably measure blood alcohol level relative to a "gold standard" method, there are significant opportunities to use this technology in consumer health applications and clinical research.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Calibration Study of a Wearable Noninvasive Blood Alcohol Monitor|
|Actual Study Start Date :||July 8, 2019|
|Actual Primary Completion Date :||February 17, 2020|
|Actual Study Completion Date :||February 17, 2020|
- Other: Smart watch to measure Blood Alcohol Level
Subjects will wear a wrist watch that measures blood alcohol level during a 1 hour period of consuming alcohol followed by a 5 hour observation period.
- Breathalyzer blood alcohol level [ Time Frame: 6 hours ]Concentration of blood alcohol measured by a breathalyzer
- Smart watch blood alcohol level [ Time Frame: 6 hours ]Concentration of blood alcohol measured by a smart watch
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 ClinicalTrials.gov identifier (NCT number): NCT03574181
|United States, Massachusetts|
|Boston University Psychiatry Research Center, Clinical Studies Unit|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Eric Devine, PhD||Boston Medical Center|