What this study is
The purpose of this study is to learn whether a structured smell training program (called "sniff training") can help improve sense of smell and quality of life in people who have experienced a reduced or lost sense of smell following a viral illness (also called post-viral anosmia).
What's being tested
- Sniff Training Kits
Intervention · OTHER
This study will test the ability of a structured smell training protocol (called "sniff training") to improved smell function. Participants will be asked to sniff inhaler cartridges containing different USDA GRAS (generally recognized as safe) odors (such as lemon, leather, strawberry, banana, etc). The amount of odor may differ, and odors may or may not be identified on the inhalers. The inhaler cartridge are provided at no charge to study participants in kits that contain four inhalers each.
Study details
- Sponsor
- University of Virginia
- Conditions
- Post-viral Anosmia · Anosmia · Hyposmia
- Enrolling
- 204 people
- Starts
- 2027-01-05
- Est. completion
- 2031-07-31
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years – 60 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Aged 10 - 60 years old
- For adults, competent and willing to give informed consent
- For minors, competent and willing to give assent, with informed consent from the parent-guardian
- Willing to undergo study procedures
- Able to follow written and verbal instructions in English
- Be able to report test/questionnaire answers via a computer, tablet, or smartphone interface
- Have a diagnosis of anosmia or hyposmia resulting from a viral infection of the upper respiratory system, with the time since the initial loss of olfactory function > 3 months and < 2 years prior
You can't join if
- Aged less than 10 years old, and greater than 60 years old
- Prisoners
- Cognitively impaired individuals; Individuals who are deemed to not have the capacity to consent by the study team through observation and direct interaction; Individuals 50-60 years old who score <31 on the TICS survey (to rule out potential dementia)
- Non-English speaking subjects
- Pregnant or breastfeeding
- Diseases of the central nervous system (including Alzheimer's disease, multiple sclerosis, Parkinson's disease, Huntington's disease, brain tumors), nasal obstruction (tumors/polyps)
- History of nasal or sinus surgery
- History of a severe head injury/concussion
- History of chronic sinus infections, allergic rhinitis, and active sinonasal disease
- History of radiation therapy to the head or neck (ever)
- Recent chemotherapy (within the last year)
- History of lung/pulmonary disease
- Diagnosis of an olfactory disorder with an etiology other than a viral infection of the upper respiratory system
- Use of the following medications (used within 3 months of enrollment):; Oral corticosteroids; Topical corticosteroids; Biologic agents used in the treatment of nasal/sinus inflammation (dupilumab, omalizumab, mepolizumab, tezepelumab); Theophylline nasal spray; Nasal vitamin A; Nasal sodium citrate
- A time since loss of olfactory function < 3 months and > 2 years.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (3)
3 openJohns Hopkins University
Baltimore, Maryland, United States
- Nicholas Rowan · Contact443-997-6467nrowan1@jhmi.edu
- Nicholas Rowan · Principal investigator
Medical University of South Carolina
Charleston, South Carolina, United States
- Rodney Schlosser · Contact843-792-2300schlossr@musc.edu
- Rodney Schlosser · Principal investigator
University of Virginia
Charlottesville, Virginia, United States
- Mackenzie Koch · Contact434-531-5354mk2nu@uvahealth.org
- Steven Munger · Principal investigator
Study team
Sponsor
University of Virginia
Study ID 303565
Principal investigator
Steven Munger
University of Virginia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.