- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04903535
External Nitric Oxide Measurement Through SNO Degradation
October 26, 2023 updated by: Nadzeya V Marozkina, Indiana University
Does a Flashlight Used to Detect Pet Biological Fluids on Human Skin and Other Surfaces Increase Gas Phase Nitric Oxide Levels?
In this study, we aim to explore the feasibility of a novel, noninvasive SNO assay to acquire physiological SNO quantification from the human ear, forehead, or hands and test this new method of analysis.
This study aims to help with the currently cumbersome and invasive procedures used to measure SNOs in the body.
The proposed activities do not unnecessarily duplicate previous experiments.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
S-nitrosylation is the covalent attachment of a nitric oxide group to cystine thiol within a protein to form an S-nitrosothiol (SNO); it has diverse regulatory roles in all mammalian cells and thus operates as a fundamental mechanism for cellular signaling and accounts for a large part of nitric oxide activity.
Though SNOs are relevant to many biological disciplines like neuronal, muscular, respiratory, and cardiovascular biology, currently there is no way to measure SNOs that is both easy to use in a clinical setting and accurate in detecting low concentrations; detection is challenging due to the labile nature of the molecules.
Low or high concentrations of these molecules could be vital indicators of incoming dangerous issues in the body.
A system to easily and accurately measure SNOs could prove useful in preventative treatments.
Ultra Violet (UV) light can break SNOs and can be used to measure nitric oxide release, but this method is not fully developed and further research is needed on the potential effect for UV to measure nitric oxide release.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46202
- Wells Center for Pediatric Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Study Population
Study sample will consist of healthy individuals. Subjects may participate if they meet the following criteria:
°Adult males or females age ≥ 1 day ≤ 75 years at time of enrollment
Description
Inclusion Criteria
- Adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment
Exclusion Criteria
- Subjects meeting the following criteria will be excluded:
- Smokers.
- Any chronic skin conditions.
- Pregnant.
- Subjects that are unable or unwilling to cooperate with specimen collection.
- Subjects with diagnosis of any medical condition that in the investigator's opinion would make them unsuitable for study participation.
- (for subjects ≥ 18) Subjects that lack the capacity to consent for themselves.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Volunteers
Study will enroll to test the assay
|
Investigator will use a Nitric Oxide Analyzer while attached to a small suction port on the subject's ear lobe to be tested for Nitric Oxide.
After getting the baseline assay, the investigator will shine a low-intensity UV Flashlight (Alonefire SV003 10W 365nm UV Flashlight) at the ear lobe for 10 seconds, repeated three times at 20 second intervals, to determine if there is photobleaching.
Then the assay will then be performed on the opposite ear lobe.
Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear).
Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear).
The subject and the investigator will wear UV goggles during the experiment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Nitric Oxide during UV light exposure
Time Frame: 30 minutes
|
NO evolved during UV light exposure from the human ear lobe, hand or forehead.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nadzeya Marozkina, PhD, MD, Indiana University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Straub AC, Lohman AW, Billaud M, Johnstone SR, Dwyer ST, Lee MY, Bortz PS, Best AK, Columbus L, Gaston B, Isakson BE. Endothelial cell expression of haemoglobin alpha regulates nitric oxide signalling. Nature. 2012 Nov 15;491(7424):473-7. doi: 10.1038/nature11626. Epub 2012 Oct 31.
- Marozkina NV, Gaston B. Nitrogen chemistry and lung physiology. Annu Rev Physiol. 2015;77:431-52. doi: 10.1146/annurev-physiol-021113-170352.
- Marozkina NV, Gaston B. S-Nitrosylation signaling regulates cellular protein interactions. Biochim Biophys Acta. 2012 Jun;1820(6):722-9. doi: 10.1016/j.bbagen.2011.06.017. Epub 2011 Jun 24.
- Palmer LA, Gaston B. S-nitrosothiol assays that avoid the use of iodine. Methods Enzymol. 2008;440:157-76. doi: 10.1016/S0076-6879(07)00809-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2021
Primary Completion (Estimated)
December 30, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
April 29, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
May 26, 2021
Study Record Updates
Last Update Posted (Actual)
October 30, 2023
Last Update Submitted That Met QC Criteria
October 26, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10839
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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