Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections (LIGHT)

May 20, 2026 updated by: David Moss
The purpose of trial is to determine if daily usage of a photobiomodulation device will decrease the incidence of upper respiratory tract infections (URI) due to COVID, influenza or other viruses.The RD-X10 device is handheld, can be self-administered, and has been shown to be safe in invivo studies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Methods: Subjects 18 years and older working at a DoD medical facility and VA medical facility will be randomized into Active Treatment (Emit Bio ) and sham (inactive device). Basic demographic information will be obtained. Subjects will use the device at home every other day for 5 minutes. Baseline viral upper respiratory PCR panel will be obtained to ensure pre-existing infections are not counted. At first sign of upper respiratory infection symptoms, subjects will contact research personnel and have viral respiratory PCR panel obtained. Research coordinators will also contact subjects every two weeks to ask if they are experiencing or have experienced any upper respiratory symptoms or if they have experienced any side effects of treatment. Subjects reporting any current symptoms or symptoms in the prior 2 weeks will have upper respiratory PCR panel obtained. Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess secondary outcomes including duration of symptoms, missed days of work, outpatient medical visits, ED visits, hospitalizations, medication prescriptions for respiratory illness and over the counter treatments.

Screening visit (Approx 30 min):

  • Obtain and document signed Informed Consent document and HIPAA Authorization
  • Verify subject eligibility based on inclusion/exclusion criteria (research coordinators may use the electronic medical record to verify inclusion/exclusion)
  • Record all medications the subject is taking
  • Collect demographic information to include phone number, email address, DoD ID, age, race, ethnicity, sex, whether they directly care for patients, what department they work in, any therapies regularly used to prevent URI (ie zinc, mouth washes, supplements), and immunocompromised state or medications that may suppress the immune system, weight (pounds), height (inches), and BMI

Randomization:

Subjects will be randomized using block randomization (blocks of 6) into one of two research treatment groups, with approximately 50 subjects in each arm for a total of 100 subjects. The study staff assigning subjects to their group will be unblinded to the groups, but patients, investigators, and study staff conducting screening and gathering data will be blinded. The unique study code will be assigned in sequential order beginning with 001.

Group 1: Active RD-X19 every other day for 3 months Group 2: Sham RD-X19 every other day for 3 months

Visit 1 (week 0) (may be same day as screening visit) (approx. 30 minutes):

  • Subject will be given the RD-X19 device and shown how to use the device
  • Subjects will be instructed to use the device for 5 minutes every other day
  • Subject will be given "Instructions for Treatment" handout

Visits 2-7 (weeks 2-12) (approx. 30 min) can be performed virtually or in person

  • Subjects will be asked if they have experienced any upper respiratory symptoms in the last 2 weeks, this may include cough, congestion, sore throat, fatigue, runny nose, sinus pain or pressure, fever (subjective or Temp >100 F), sneezing.
  • Subjects experiencing any of the above symptoms will be tested for URI causing viruses using PCR based testing.
  • Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess secondary outcomes including duration of symptoms, missed days of work, outpatient medical visits, ED visits, hospitalizations, medication prescriptions for respiratory illness and over the counter treatments. They will also be assessed daily using the WURSS 24 (Wisconsin Upper Respiratory Symptom Survey) daily symptom report until they report a score of 0 for question 1 (How sick do you feel today?)
  • Subjects who have not experienced any URI symptoms will be assessed for adherence to RDX19 over the previous 2 weeks and encouraged to continue using the device. They will also be asked if they are experiencing any side effects of the treatment such as throat or mouth irritation, sores in the mouth or on the lips or any other perceived side effects.

Device will only be used for a single patient and should be returned to research staff at the end of the study for disposal.

Study Type

Interventional

Enrollment (Estimated)

130

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Active Duty and DoD Beneficiaries (i.e. former military, spouse, dependent child) aged 18 years and older who work in the Mike O'Callaghan Military Medical Center at Nellis Air Force Base.

Exclusion Criteria:

  • Unable to comfortably insert RD-X19 into the mouth and keep in place for 5 minutes
  • Plans for head, neck or mouth surgery during the study period
  • Plans for major dental procedures (ie implants, wisdom teeth extraction etc) during the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Active RD-X19 every other day for 3 months
Device: RD-X19
  • Subject will be given the RD-X19 device and shown how to use the device
  • Subjects will be instructed to use the device for 5 minutes every other day
  • Subject will be given "Instructions for Treatment" handout
Sham Comparator: Group 2: Sham RD-X19 every other day for 3 months
Device: RD-X19 Sham
  • Subject will be given the sham RD-X19 device and shown how to use the device
  • Subjects will be instructed to use the sham device for 5 minutes every other day
  • Subject will be given "Instructions for Treatment" handout

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in PCR confirmed URI (any virus)
Time Frame: visit 2 (week 2), visit 3 (week 4), visit 4 (week 6), visit 5 (week 8), visit 6 (week 10), visit 7 (week 12)
difference in PCR confirmed URI (any virus) between active and sham groups between treatment period
visit 2 (week 2), visit 3 (week 4), visit 4 (week 6), visit 5 (week 8), visit 6 (week 10), visit 7 (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of symptoms
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess duration of symptoms (days)
upper respiratory infection duration, an average of 2 weeks
missed days of work
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess missed days of work
upper respiratory infection duration, an average of 2 weeks
outpatient visits
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number of outpatient visits
upper respiratory infection duration, an average of 2 weeks
emergency department visits
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number of emergency department visits
upper respiratory infection duration, an average of 2 weeks
hospitalizations
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number of hospitalizations
upper respiratory infection duration, an average of 2 weeks
Wisconsin Upper Respiratory Symptom Survey (WURSS 24)
Time Frame: upper respiratory infection duration, an average of 2 weeks

Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess daily symptom severity score using WURSS 24.

The WURSS 24 is an illness-specific quality of life instrument, designed to assess the negative impact of acute upper respiratory infections. Subjects rate their symptoms and daily impairments using 0-7-point Likert scales. Minimum value is 0, maximum value is 154. Higher score means worse outcome.
upper respiratory infection duration, an average of 2 weeks
number and type of medication prescriptions for respiratory illness
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number and type medication prescriptions for respiratory illness. Example: 1 medication prescription, medication prescription=Tamiflu.
upper respiratory infection duration, an average of 2 weeks
number and type of over the counter treatments used
Time Frame: upper respiratory infection duration, an average of 2 weeks
Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number an d type of over the counter treatments used. Example: 1 OTC treatment used, OTC treatment=ibuprofen.
upper respiratory infection duration, an average of 2 weeks
differences in incidence of URI amongst different viruses from PCR panels
Time Frame: through study duration, an average of 12 weeks
differences in incidence of URI amongst different viruses from PCR panels
through study duration, an average of 12 weeks
treatment side effects
Time Frame: through study duration, an average of 12 weeks
treatment side effects
through study duration, an average of 12 weeks
adherence to daily use of RD-X19 device throughout study
Time Frame: through study duration, an average of 12 weeks
adherence to daily use of RD-X19 device as reported to study staff at all visits (1-7)
through study duration, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Moss

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

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOFMC.2026.0032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographic and clinical data will be acquired from participants. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier for the NLM Data Archive (NDA) (clinicaltrials.gov) will be collected for each subject. Sufficient data from this project will be preserved to enable sharing via NDA data of sufficient quality to validate and replicate research findings described in the Aims. NLM requires data measured from human subjects to be shared using the NDA. Demographic data, clinical data, data collection tools and study protocols will be made available in the NDA.

IPD Sharing Time Frame

All data will be deposited to clinicaltrials following the usual NDA data submission dates.

IPD Sharing Access Criteria

Data will be findable for the research community through the NDA Collection that will be established when this application is funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.

The research community will have access to data when the study ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. We will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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