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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05384561
Other study ID # OTTODC192022JFUQTR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2022
Est. completion date March 2023

Study information

Verified date May 2022
Source Université du Québec à Trois-Rivières
Contact Johannes A Frasnelli, PhD
Phone 18193765011
Email johannes.a.frasnelli@uqtr.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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) with a placebo group. 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). The placebo group will train themselves with an odorless substance. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date March 2023
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
Smell training
For 12 weeks, morning and evening, smell four different odors or four odorless substances for a total of five minutes per session.

Locations

Country Name City State
Canada Université du Québec à Trois-Rivières Trois-Rivières Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Primary 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. Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Primary 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. Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Primary 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. Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Primary The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS) 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. Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Secondary 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. Measurement will be taken at time zero (pre-intervention)
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