External Nitric Oxide Measurement Through SNO Degradation

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04903535
Collaborator
(none)
100
2
20
50
2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Alonefire SV003 10W 365nm UV Flashlight

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Does a Flashlight Used to Detect Pet Biological Fluids on Human Skin and Other Surfaces Increase Gas Phase Nitric Oxide Levels?
Actual Study Start Date :
Apr 29, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Healthy Volunteers

Study will enroll 5 healthy volunteers to test the assay

Device: Alonefire SV003 10W 365nm UV Flashlight
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.

Outcome Measures

Primary Outcome Measures

  1. Change in Nitric Oxide during UV light exposure [30 minutes]

    NO evolved during UV light exposure from the human ear lobe, hand or forehead.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riley Hospital for Children Indianapolis Indiana United States 46202
2 Wells Center for Pediatric Research Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University

Investigators

  • Principal Investigator: Nadzeya Marozkina, PhD, MD, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nadzeya V Marozkina, Assistant Research Professor, Indiana University
ClinicalTrials.gov Identifier:
NCT04903535
Other Study ID Numbers:
  • 10839
First Posted:
May 26, 2021
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022