External Nitric Oxide Measurement Through SNO Degradation

NCT04903535 | Enrolling By Invitation FDA Device

• 1 other identifier: 10839
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, we aim to explore the feasibility of a novel, noninvasive SNO assay to acquire physiological SNO quantification from various parts of the human body 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.

Conditions

Healthy; Unconscious

Outcome Measures

Primary Outcomes (1)

• Change in Nitric Oxide during UV light exposure

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

  30 minutes

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Study will enroll to test the assay

Device: Alonefire SV003 10W 365nm UV Flashlight

Interventions

Alonefire SV003 10W 365nm UV Flashlight DEVICE

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.

Healthy Volunteers

Eligibility Criteria

• Age: 1 Day - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Wells Center for Pediatric Research

Indianapolis, Indiana, 46202, United States

Location

Related Publications (4)

• Marozkina NV, Gaston B. Nitrogen chemistry and lung physiology. Annu Rev Physiol. 2015;77:431-52. doi: 10.1146/annurev-physiol-021113-170352.

  PMID: 25668023 BACKGROUND

• 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.

  PMID: 23123858 BACKGROUND

• 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.

  PMID: 21745537 BACKGROUND

• 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.

  PMID: 18423216 BACKGROUND

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadzeya Marozkina, PhD, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: Healthy Volunteers

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 26, 2021
• Study Start: May 10, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)