HealthyNCT04903535
External Nitric Oxide Measurement Through SNO Degradation
A study testing Alonefire SV003 10W 365nm UV Flashlight in people with Healthy and Unconscious, run by Indiana University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Unconscious
- What is being tested?
- Alonefire SV003 10W 365nm UV Flashlight
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Riley Hospital for Children
Indianapolis, Indiana, 46202
Wells Center for Pediatric Research
Indianapolis, Indiana, 46202
About this study
Official title: 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 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.
- Conditions
- Healthy, Unconscious
- Being tested
- Alonefire SV003 10W 365nm UV Flashlight
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alonefire SV003 10W 365nm UV FlashlightDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Study will enroll to test the assay Receives: Device: Alonefire SV003 10W 365nm UV Flashlight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nitric Oxide during UV light exposure
NO evolved during UV light exposure from the human ear lobe, hand or forehead.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start10 May 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy Volunteers
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadzeya V Marozkina, Indiana University
- Investigators
- Nadzeya Marozkina, PhD, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903535
- Sponsor's protocol ID
- 10839
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2021
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 25668023Straub 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 23123858Marozkina 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 21745537Palmer 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Flashlight Used to Detect Pet Biological Fluids on Human Skin and Other Surfaces Increase Gas Phase Nitric Oxide Levels?
- ClinicalTrials.gov ID
- NCT04903535
- Acronym / sponsor ID
- 10839
- Conditions
- Healthy, Unconscious
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy Volunteers
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Alonefire SV003 10W 365nm UV FlashlightStudy will enroll to test the assay |
Who may qualify
- Ages
- 1 day to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult males or females age ≥ 1 day and ≤ 75 years at time of enrollment
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alonefire SV003 10W 365nm UV FlashlightInvestigator 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. | Device | Healthy Volunteers |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 25668023Marozkina NV, Gaston B. Nitrogen chemistry and lung physiology. Annu Rev Physiol. 2015;77:431-52. doi: 10.1146/annurev-physiol-021113-170352.
- Background: PubMed 23123858Straub 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.
- Background: PubMed 21745537Marozkina 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.
- Background: PubMed 18423216Palmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadzeya Marozkina, PhD, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alonefire SV003 10W 365nm UV Flashlight in people with Healthy and Unconscious, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nitric Oxide during UV light exposure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04903535, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.