OTTODC19: Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19

Sponsor

Université du Québec à Trois-Rivières (Other)

Overall Status

Recruiting

CT.gov ID

NCT05384561

Collaborator

(none)

105

Enrollment

Location

Arms

Anticipated Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyposmia COVID-19 Parosmia Anosmia SARS-CoV-2 Infection	Other: Smell training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

L'entraînement Olfactif Comme Traitement de la Dysfonction Olfactive Post COVID-19

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemosensory training group 1 For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, Orange, and eugenol, for a total of five minutes per session.	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. Other Names: Chemosensory training group
Experimental: Chemosensory training group 2 For 12 weeks, morning and evening, smell four odors namely coffee aroma, cheese aroma, strawberries, and limon, for a total of five minutes per session.	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. Other Names: Chemosensory training group
Placebo Comparator: Chemosensory training group 3 For 12 weeks, morning and evening, smell four same odorless substance.	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. Other Names: Chemosensory training group

Arm

Intervention/Treatment

Experimental: Chemosensory training group 1

For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, Orange, and eugenol, for a total of five minutes per session.

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.

Other Names:

Chemosensory training group

Experimental: Chemosensory training group 2

For 12 weeks, morning and evening, smell four odors namely coffee aroma, cheese aroma, strawberries, and limon, for a total of five minutes per session.

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.

Other Names:

Chemosensory training group

Placebo Comparator: Chemosensory training group 3

For 12 weeks, morning and evening, smell four same odorless substance.

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.

Other Names:

Chemosensory training group

Outcome Measures

Primary Outcome Measures

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) [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.
Changes from baseline in olfactory score on the Sniffin's Sticks test [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.
n-house test for chemosensory dysfunction (TMSC) [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.
Parosmia and phantosmia assessment test [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.
The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS) [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.

Secondary Outcome Measures

Nasal Obstruction Symptom Evaluation (NOSE) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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