Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections

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.

• RD-X19 (Device): * 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
• RD-X19 Sham (Device): * 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

Primary outcomes

• difference in PCR confirmed URI (any virus) [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

Secondary outcomes

• duration of symptoms [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)
• missed days of work [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
• outpatient visits [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
• emergency department visits [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
• hospitalizations [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
• Wisconsin Upper Respiratory Symptom Survey (WURSS 24) [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.
• number and type of medication prescriptions for respiratory illness [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.
• number and type of over the counter treatments used [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.
• differences in incidence of URI amongst different viruses from PCR panels [through study duration, an average of 12 weeks]: differences in incidence of URI amongst different viruses from PCR panels
• treatment side effects [through study duration, an average of 12 weeks]: treatment side effects
• adherence to daily use of RD-X19 device throughout study [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)

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

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