SniffTrain: Effectiveness of Sniff Training in the Treatment of Post-Viral Anosmia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-60
SponsorUniversity of Virginia
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sniff Training Kits
Other interventionThis 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.
Treatment groups
204 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Sniffing named odorsActive comparator 1 intervention
Group B: Arm 2: Sniffing unnamed odorsActive comparator 1 intervention
Group C: Arm 3: Control ArmOther 1 intervention
Trial outcomes
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).
Time frame
From enrollment to the end-of-study visit at 52 weeksSecondary outcomes
1
Improvement in social and emotional loneliness
Patients with smell loss often experience negative changes in mental health, including increased loneliness. The investigators will use the well-validated De Jong Gierveld short scale questionnaire, composed of six questions, to assess changes in the levels of emotional and social loneliness for each participant. Higher scores on the six-point scale indicates greater loneliness.
Time frame
From enrollment to the end-of-study visit at 52 weeks2
Improvement in quality of life
Patients with smell loss often experience negative changes in their quality of life. To assess changes in health-related quality of life, the investigators will administer the SF-12v2 Health Survey questionnaire (or alternatively the Child Health Questionnaire for participants younger than 18 years old). The SF12v2 provides summary, norm-based scores for mental and physical components, with scores of 50 corresponding to the US population average. Higher scores indicate better health-related quality of life.
Time frame
From enrollment to the end-of-study visit at 52 weeks3
Changes in olfactory-associated quality of life
Patients with smell loss often experience negative changes in their quality of life. To assess changes in quality of life aspects that have been previously shown to be correlated with olfactory function, the investigators will administer the olfactory-salient Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS). Higher scores on this 51 point scale indicate a greater negative impact of olfactory dysfunction on quality of life.
Time frame
From enrollment to the end-of-study visit at 52 weeks4
Changes in cognitive function
Several studies have suggested that smell training can improve cognitive function. The investigators will administer the Montreal Cognitive Assessment (MoCA) to measure changes in multiple domains of cognitive function in study participants. The MoCA will only be administered to participants ages 14 years old and up. Higher scores on this 30 point scale indicate better cognitive performance.
Time frame
From enrollment to the end-of-study visit at 52 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Johns Hopkins University
Collaborator
Medical University of South Carolina
Collaborator
Source ClinicalTrials.gov
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