Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-01-20 @ 7:06 AM
Study NCT ID:
NCT05384561
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olfactory Training As a Treatment for Olfactory Dysfunction Post COVID-19
Sponsor:
Université du Québec à Trois-Rivières
Organization:
Study Overview
Official Title:
L'entraînement Olfactif Comme Traitement De La Dysfonction Olfactive Post COVID-19
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OTTODC19
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.
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
● 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: