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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05384561
Recruitment Status : Recruiting
First Posted : May 20, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Université du Québec à Trois-Rivières

Tracking Information
First Submitted Date  ICMJE May 19, 2022
First Posted Date  ICMJE May 20, 2022
Last Update Posted Date May 26, 2022
Estimated Study Start Date  ICMJE May 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2022)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19
Official Title  ICMJE L'entraînement Olfactif Comme Traitement de la Dysfonction Olfactive Post COVID-19
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyposmia
  • COVID-19
  • Parosmia
  • Anosmia
  • SARS-CoV-2 Infection
Intervention  ICMJE 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 Name: Chemosensory training group
Study Arms  ICMJE
  • 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.
    Intervention: Other: Smell training
  • 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.
    Intervention: Other: Smell training
  • Placebo Comparator: Chemosensory training group 3
    For 12 weeks, morning and evening, smell four same odorless substance.
    Intervention: Other: Smell training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2022)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johannes A Frasnelli, PhD 18193765011 ext 3589 johannes.a.frasnelli@uqtr.ca
Contact: Frank Cloutier, PhD 18193765011 ext 3360 frank.cloutier@uqtr.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05384561
Other Study ID Numbers  ICMJE OTTODC192022JFUQTR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Université du Québec à Trois-Rivières
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Université du Québec à Trois-Rivières
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johannes A Frasnelli, PhD Université du Québec à Trois-Rivières
PRS Account Université du Québec à Trois-Rivières
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP