NCT07857083

Brief Summary

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 5, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 5, 2027

Expected
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2031

Last Updated

October 5, 2026

Status Verified

September 1, 2026

Enrollment Period

4.6 years

First QC Date

September 25, 2026

Last Update Submit

September 30, 2026

Conditions

Post-viral AnosmiaAnosmiaHyposmia

Keywords

smellolfactionodorsniffing

Outcome Measures

Primary Outcomes (1)

  • Improvement in Odor Perception

    The investigators will use a highly-validated psychophysical smell test (the Sniffin' Sticks Extended Test) to assess changes in olfactory perception and their duration. This test is the primary outcome measure. The resulting TDI score reflects performance on three related test components that measure odor detection Threshold, odor Discrimination, and odor Identification. The scale is 0-48, with higher scores indicating greater function. Investigators will also administer another highly-validated psychophysical smell test, the University of Pennsylvania Smell Identification Test (UPSIT). The score on this 40 point test will not be used to determine the primary outcome but will allow direct comparisons to some other studies that used this measure (higher scores indicated greater function).

    From enrollment to the end-of-study visit at 52 weeks

Secondary Outcomes (4)

  • Improvement in social and emotional loneliness

    From enrollment to the end-of-study visit at 52 weeks

  • Improvement in quality of life

    From enrollment to the end-of-study visit at 52 weeks

  • Changes in olfactory-associated quality of life

    From enrollment to the end-of-study visit at 52 weeks

  • Changes in cognitive function

    From enrollment to the end-of-study visit at 52 weeks.

Study Arms (3)

Arm 1: Sniffing named odors

ACTIVE COMPARATOR

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.

Other: Sniff Training Kits

Arm 2: Sniffing unnamed odors

ACTIVE COMPARATOR

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.

Other: Sniff Training Kits

Arm 3: Control Arm

OTHER

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.

Other: Sniff Training Kits

Interventions

Sniff Training KitsOTHER

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.

Arm 1: Sniffing named odorsArm 2: Sniffing unnamed odorsArm 3: Control Arm

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You 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 may not qualify 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Munger

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nino McHedlishvili

CONTACT

434-243-3643nm6s@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Otolaryngology-Head & Neck Surgery

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 5, 2026

Study Start (Estimated)

January 5, 2027

Primary Completion (Estimated)

July 31, 2031

Study Completion (Estimated)

July 31, 2031

Last Updated

October 5, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)