| Registry | NCT07857083 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 204 (Estimated) |
| Sponsor | University of Virginia (Other); collaborators: National Institutes of Health (NIH), Johns Hopkins University, Medical University of South Carolina |
| Conditions | Post-viral Anosmia, Anosmia, Hyposmia |
| Interventions | Sniff Training Kits (Other) |
| Dates | start 2027-01-05 (estimated), primary completion 2031-07-31 (estimated), completion 2031-07-31 (estimated), first posted 2026-10-05, last updated 2026-10-05 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Post-viral Anosmia All trials for Anosmia All trials of Sniff Training Kits
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm 1: Sniffing named odors | Active comparator | Other: Sniff Training Kits | Participants randomly assigned to Arm 1 will receive sniff training kits containing four inhaler cartridges, with each cartridge containing a different odor (such as lemon, leather, rose, banana, etc). Odor names will be on the cartridges. Participants are instructed to sniff each inhaler cartridge in the morning and evening for 12 weeks. After this initial 12 weeks, participants will receive a new kit which may contain four different odors. These new inhaler cartridges will be sniffed for an additional 12 weeks. At several points in the study, participants will take smell tests or answer questionnaires to assess their ability to smell, their quality of life, and their psychological and neurological health. |
| Arm 2: Sniffing unnamed odors | Active comparator | Other: Sniff Training Kits | Arm 2 will be identical to Arm 1 with the exception that the inhaler cartridges provided to participants randomly assigned to Arm 2 will not have labels identifying the aroma contained in each cartridge. |
| Arm 3: Control Arm | Other | Other: Sniff Training Kits | Arm 3 will be identical to Arm 2 with the exception that the inhaler cartridges will not contain the same amount of odor as in the inhaler cartridges used in Arm 2. |
Sex: All, ages: 10 Years to 60 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Johns Hopkins University | Baltimore, Maryland | United States | |
| Medical University of South Carolina | Charleston, South Carolina | United States | |
| University of Virginia | Charlottesville, Virginia | United States |