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

Primary Purpose

Hyposmia, COVID-19, Parosmia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Smell training
Sponsored by
Université du Québec à Trois-Rivières
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyposmia focused on measuring Olfactory training, Chemosensory impairments, Persistent smell impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Université du Québec à Trois-RivièresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Chemosensory training group 1

Chemosensory training group 2

Chemosensory training group 3

Arm Description

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

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.

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

Outcomes

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)
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
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)
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
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)
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)
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.

Full Information

First Posted
May 19, 2022
Last Updated
May 20, 2022
Sponsor
Université du Québec à Trois-Rivières
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1. Study Identification

Unique Protocol Identification Number
NCT05384561
Brief Title
Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19
Acronym
OTTODC19
Official Title
L'entraînement Olfactif Comme Traitement de la Dysfonction Olfactive Post COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université du Québec à Trois-Rivières

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyposmia, COVID-19, Parosmia, Anosmia, SARS-CoV-2 Infection
Keywords
Olfactory training, Chemosensory impairments, Persistent smell impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemosensory training group 1
Arm Type
Experimental
Arm Description
For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, Orange, and eugenol, for a total of five minutes per session.
Arm Title
Chemosensory training group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Chemosensory training group 3
Arm Type
Placebo Comparator
Arm Description
For 12 weeks, morning and evening, smell four same odorless substance.
Intervention Type
Other
Intervention Name(s)
Smell training
Other Intervention Name(s)
Chemosensory training group
Intervention Description
For 12 weeks, morning and evening, smell four different odors or four odorless substances for a total of five minutes per session.
Primary Outcome Measure Information:
Title
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)
Description
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)
Title
Changes from baseline in olfactory score on the Sniffin's Sticks test
Description
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)
Title
n-house test for chemosensory dysfunction (TMSC)
Description
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)
Title
Parosmia and phantosmia assessment test
Description
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)
Title
The abridged version of the Questionnaire of Olfactory Disorders - Negative Statements (sQOD-NS)
Description
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) and 12 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation (NOSE)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes A Frasnelli, PhD
Phone
18193765011
Ext
3589
Email
johannes.a.frasnelli@uqtr.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Cloutier, PhD
Phone
18193765011
Ext
3360
Email
frank.cloutier@uqtr.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes A Frasnelli, PhD
Organizational Affiliation
Université du Québec à Trois-Rivières
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université du Québec à Trois-Rivières
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 4M3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Cloutier, PhD
Phone
18193765011
Ext
3360
Email
frank.cloutier@uqtr.ca
First Name & Middle Initial & Last Name & Degree
Simon Bérubé, Med Student
Email
simon.berube.1@umontreal.ca

12. IPD Sharing Statement

Learn more about this trial

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

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