Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité du Québec à Trois-Rivières
About this trial
Olfactory dysfunction is a defining symptom of COVID-19 infection. Studies have demonstrated improved olfaction in patients with post infectious olfactory dysfunction after an olfactory training (OT). The aim of this study is to assess the clinical outcomes of olfactory training (12 weeks) therapy in the treatment of persistent olfactory dysfunctions after COVID-19. Specially, we aim to compare the effectiveness of two different olfactory training (different odors).
A group will train themselves with 4 scents (rose, orange, clove and eucalyptus) and another group with 4 different scents (cheese, coffee, strawberries and lemon). Olfaction sensory evaluation will be performed by using different olfaction tests (Sniffin' Sticks and UPSIT) and complete questionnaires to assess olfactory perception and particularly parosmia and phantosmia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient diagnosed positive for COVID-19 with persistent olfactory dysfunction
Willing and able to provide written informed consent
Understand and read the French language
Have an internet connection and a working email address
Disqualifiers
Anosmia and hyposmia pre-covid-19
Be known chronic rhinosinusitis with or without nasal polyposis
Have received radiotherapy or chemotherapy for Head and Neck Tumors
Have a diagnosis of Alzheimer's, Parkinson's, multiple sclerosis or any other neurodegenerative disease 5. Have a brain tumor or ENT diagnosis 6. History of naso-sinus surgery; 7. History of traumatic brain injury
Trial design
Design model
Parallel
Treatments tested in this trial
Smell training
Other interventionFor 12 weeks, morning and evening, smell four different odors or four odorless substances for a total of five minutes per session.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Chemosensory training group 1Experimental treatment 1 intervention
Group B: Chemosensory training group 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes from baseline in olfactory score on the University of Pennsylvania Identification Test (UPSIT) [ Time Frame: Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
The UPSIT includes 4 odor-impregnated booklets that contain 10 forced-choice multiple choice questions each for participants to scratch-and-sniff to identify various odors and is a commercially available test. Normosmia is defined as ≥34 for males and ≥35 for females, and a change of 4 points or more from baseline indicates a clinically meaningful result.
Time frame
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)2
Changes from baseline in olfactory score on the Sniffin's Sticks test
Sniffin' Sticks test and Taste strips: Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.
Time frame
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)3
n-house test for chemosensory dysfunction (TMSC)
The TMSC is a 55-item questionnaire evaluating the three chemical senses: olfaction, taste and the trigeminal sense. First, questions with a 10-point visual analog scale make a subjective self-assessment of each of the three senses. Multiple-choice questions establish the precise characteristics of the dysfunctions of each of the senses if they are present. Secondly, a psychophysical test is administered remotely using substances typical of North American cuisines. Substances are first sniffed (peanut butter, jam, vinegar, coffee) then tasted (peanut butter, jam, salt water (1 tsp/250mL), sugar water (3 tsp/250mL)). The perceived intensity of each of the substances is reported each time on a visual analogue scale of 10 points.
Time frame
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)4
Parosmia and phantosmia assessment test
This test has a first part with four questions that aim to assess the presence of parosmia or phastosmia. Patients who have reported parosmia or phantosmia will be asked to complete a second part with six questions focusing on the quality of their olfactory distortion.
Time frame
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)Secondary outcomes
1
Nasal Obstruction Symptom Evaluation (NOSE)
A visual analog scale (scale from "not a problem" to "severe problem") is used by participants to assess their nasal obstruction. The duration of this test is approximately 2 minutes.
Time frame
Measurement will be taken at time zero (pre-intervention)Sponsors and contacts
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Source ClinicalTrials.gov