Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3, Canada
Location status: Recruiting
NCT Number: NCT05384561
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Trois-Rivières, Quebec, G8Z 4M3, Canada
Location status: Recruiting
Patients who meet the criteria, who have agreed to participate in this research project and sign the consent form will be placed in one of the following two groups:
● Experimental group (olfactory training)
■ Participants will bring their training kit with them following the olfactory evaluation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For 12 weeks, morning and evening, smell four different odors or four odorless substances for a total of five minutes per session.
Other names: Chemosensory training group
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)
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)
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)
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)
The sQOD-NS is a validated questionnaire that measures the quality of life specific to olfactory functions. The questionnaire measures 7 items with a 4-point Likert scale.
Time frame: Measurement will be taken at time zero (pre-intervention)
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.
Contact information is provided by the study sponsor or research team.
Frank Cloutier, PhD
CONTACT
18193765011 ext. 3360
Johannes A Frasnelli, PhD
CONTACT
18193765011 ext. 3589
Université du Québec à Trois-Rivières
Other
L'entraînement Olfactif Comme Traitement De La Dysfonction Olfactive Post COVID-19
Acronym: OTTODC19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05184192
Anosmia, COVID-19
St Louis, Missouri, United States
View Trial DetailsNCT05445921
Anosmia, COVID-19
St Louis, Missouri, United States
View Trial DetailsNCT04789499
Ageusia, Anosmia
St Louis, Missouri, United States
View Trial DetailsNCT04853836
Anosmia, Behavior
Roma, Italy
View Trial Details