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Enrolling by invitationNCT04903535Updated Feb 9, 2026

External Nitric Oxide Measurement Through SNO Degradation

An interventional study of Alonefire SV003 10W 365nm UV Flashlight in Healthy and Unconscious, sponsored by Indiana University. Enrolling by invitation at 2 sites in United States. Open to participants aged 1 Day to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Indiana University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
1 Day to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
  • Unconscious

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03

In context

Unconsciousness

60 studies on the registry are indexed under Unconsciousness; 9 are open to participants now.

This study's planned enrollment of 150 is above the median of 50 across 37 interventional studies indexed under Unconsciousness.

Browse Unconsciousness studies →

Lead sponsor

Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Healthy Volunteers

    Study will enroll to test the assay

    Device: Alonefire SV003 10W 365nm UV Flashlight

Interventions

  • DeviceAlonefire 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.

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What researchers measure

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.

    Time frame: 30 minutes

07

Study locations

2 sites
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References and documents

Publications

  • Marozkina NV, Gaston B. Nitrogen chemistry and lung physiology. Annu Rev Physiol. 2015;77:431-52. doi: 10.1146/annurev-physiol-021113-170352. PubMed 25668023 ↗
  • 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. PubMed 23123858 ↗
  • 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. PubMed 21745537 ↗
  • 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. PubMed 18423216 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04903535
Lead sponsor
Indiana University
Responsible party
Nadzeya V Marozkina (Assistant Research Professor, Indiana University) — Principal investigator
First posted
May 26, 2021
Start date
May 10, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Feb 9, 2026

Study contacts

Nadzeya Marozkina, PhD, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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