Olfactory Training As a Treatment for Olfactory Dysfunction Post COVID-19 (OTTODC19)

December 11, 2024 updated by: Université du Québec à Trois-Rivières

L'entraînement Olfactif Comme Traitement De La Dysfonction Olfactive Post COVID-19

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

  1. Initial meeting: Each participant will be asked for a session of approximately 1:30 h which will take place in a ventilated room in the laboratory of Dr. Johannes Frasnelli at UQTR. During the hour preceding this evaluation, subjects will be asked not to smoke, eat or drink anything other than water and not to wear perfume. A research assistant will be responsible for completing the various tests. During this meeting, the following tests will be done:

    • Data collection (case report form): medical and socio-demographic questionnaire that will be used for data analysis.
    • A nasal obstruction criterion scale - NOSE
    • A subjective questionnaire on the impact of OD on quality of life - sQOD-NS
    • Chemosensory Dysfunction Home Test - TMSC
    • The UPSIT 40 test
    • The Sniffin' Sticks test
    • Test to assess the manifestation of parosmia and phantosmia
    • Teaching on the olfactory rehabilitation kit and explanation of the training protocol.

  2. Treatment (12 weeks): Following the initial meeting, patients can begin training:

    ■ Participants will bring their training kit with them following the olfactory evaluation.

  3. Final meeting: After 12 weeks of treatment, an appointment will be scheduled with the participant. The olfactory evaluation will be done as described in the initial meeting. During the hour preceding this evaluation, subjects will be asked not to smoke, eat or drink anything other than water and not to wear perfume. A research assistant will be responsible for administering the various tests. During this meeting, the following tests will be done:

    • A subjective questionnaire on the impact of OD on quality of life - sQOD-NS
    • Chemosensory Dysfunction Home Test - TMSC
    • The UPSIT 40 test
    • The Sniffin' Sticks test
    • Test to assess the manifestation of parosmia and phantosmia

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Changes from baseline in olfactory score on the Sniffin's Sticks test
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.
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
n-house test for chemosensory dysfunction (TMSC)
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.
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
Parosmia and phantosmia assessment test
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.
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)
The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS)
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.
Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal Obstruction Symptom Evaluation (NOSE)
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.
Measurement will be taken at time zero (pre-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec à Trois-Rivières

Investigators

  • Principal Investigator: Johannes A Frasnelli, PhD, Université du Québec à Trois-Rivières

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTTODC192022JFUQTR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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