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

NCT ID: NCT05384561

Last Updated: 2024-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2025-09-30

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).

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.

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

Conditions

Hyposmia; COVID-19; Parosmia; Anosmia; SARS-CoV-2 Infection

Keywords

Olfactory training; Chemosensory impairments; Persistent smell impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Smell training

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Smell training

Intervention Type: OTHER

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

Interventions

Smell training

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

Intervention Type: OTHER

Other Intervention Names

Chemosensory training group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université du Québec à Trois-Rivières

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johannes A Frasnelli, PhD

Role: PRINCIPAL_INVESTIGATOR

Université du Québec à Trois-Rivières

Locations

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Johannes A Frasnelli, PhD

Role: CONTACT

Phone: 18193765011

Email: johannes.a.frasnelli@uqtr.ca

Frank Cloutier, PhD

Role: CONTACT

Phone: 18193765011

Email: frank.cloutier@uqtr.ca

Facility Contacts

Frank Cloutier, PhD

Role: primary

Simon Bérubé, Med Student

Role: backup

Other Identifiers

OTTODC192022JFUQTR

Identifier Type: -

Identifier Source: org_study_id