Loss of SmellPhase 4NCT06066307
Olfactory Performance in Culinary Arts Students
A Phase 4 study testing Olfactory training in people with Loss of Smell and Olfactory Disorder, run by Leigh Sowerby at 1 site in Canada.
Trial summary
The COVID-19 pandemic brought impaired smell and taste to the forefront of international public awareness and clinical importance. Loss of smell can impair awareness of environmental hazards, alter appetite, and have negative effects on social behavior and well-being. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loss of Smell, Olfactory Disorder
- What is being tested?
- Olfactory training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2023to 21 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- enrolled in an introductory training program at Fanshawe collage (Culinary arts or Information Technology)
- capable of providing informed written consent
- capable of reading and writing in English
Who cannot join
- Participants with a history of anosmia, and chronic sinus disease.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Fanshawe College
London, Ontario, N5Y 5R6
Taciano Rocha, Ph.D, ACRP-CP, 5196466100 ext. 61125, taciano.rocha@sjhc.london.on.ca
About this study
The COVID-19 pandemic brought impaired smell and taste to the forefront of international public awareness and clinical importance. Loss of smell can impair awareness of environmental hazards, alter appetite, and have negative effects on social behavior and well-being. Despite the significant functional impact associated with impaired olfaction, few effective treatments are available. Olfactory training (OT), the mainstay of treatment, is a self-administered therapy which involves a routine of repetitive brief odor exposures over several weeks. The process has been shown to improve odor discrimination, identification and detection threshold. However, the structured design and daily time commitment may be difficult to adopt for some patients, leading to poor compliance. Moreover, OT only exposes patients to a limited number of odours, failing to replicate the complexity of odor mixtures experienced daily in our chemosensory environment. OT has mainly been studied with four conventional odours encompassing the major odor categories; phenyl ethyl alcohol/rose (flowery odor), eucalyptol (aromatic), citronellal/lemon (fruity), and eugenol (clove) (resinous); however, this neglects the importance of emphasizing odors that culturally specific or personally relevant to the patient. For some patients, these factors could hinder their ability to adopt and comply with therapy.
In contrast, cooking is a culturally ubiquitous activity that is already performed daily by most people, and naturally exposes us to personally meaningful and culturally relevant odors. However, there have been no published studies investigating the impact that odors encountered during meal preparation have on olfactory performance and development. The present study aims to compare the olfactory effects of culinary skills training to those of a conventionally designed OT program. To achieve this, olfactory testing will be conducted on students enrolled in a professional culinary skills training program at Fanshawe College, and a control group consisting of students in non-olfactory dependent programs at the same institution. To compare the effect of cooking to conventional OT, the study will be repeated for a second semester and students will be asked to perform concurrent OT.
Read the detailed description
This factorially designed randomized control trial is designed to compare the effects of a culinary skills training program to a typical olfactory training program on olfactory ability, awareness, and quality of life. Students enrolled in a culinary skills training program and those in a different discipline with no relevant dependence on olfactory function (information technology) will have their olfactory performance assessed before and after the completion of the program semester. The investigators will then repeat the experiment in the subsequent semester with a new group of students, asking them to perform routine OT throughout the semester.
Objective olfactory assessment will be performed with the Sniffin'Sticks olfactory test kit (Burghart, Wedel, Germany). Additionally, they will be asked to complete questionnaires that evaluate their olfactory awareness, the 32-item Odor Awareness Scale. The study aims to compare the effect of routine exposure to the chemosensory environment of cooking with conventional odor training (OT) in improving olfactory function.
Hypothesis and Objectives Objective 1: To compare the effect of culinary skill training to a control group on objective olfactory performance, subjective olfactory awareness and olfactory related quality of life.
- Hypothesis 1: Participants who complete a semester of culinary skill training will experience improvements in odor threshold discrimination identification scores compared to students studying in non-chemosensory dependent fields.
- Hypothesis 2: Participants who complete a semester of culinary skill training will experience improvements in subjective odor awareness compared to students studying in non- chemosensory dependent fields.
- Hypothesis 3: Participants who complete a semester of culinary skill training will experience improvements in olfactory specific quality of life compared to students studying in non- chemosensory dependent fields.
Objective 2: To compare the effect of culinary skill training with OT to conventional OT on objective olfactory performance, subjective olfactory awareness and olfactory related quality of life
- Hypothesis 1: Participants who complete a semester of culinary skill training with OT will experience further improvements in odor their threshold discrimination identification scores.
- Hypothesis 2: Participants who complete a semester of culinary skill training with OT will experience improvements in subjective odor awareness that are greater in magnitude to the improvements gained by participants practicing OT.
- Hypothesis 3: Participants who complete a semester of culinary skill training with OT will experience improvements in olfactory specific quality of life that are greater in magnitude to the improvements gained by participants practicing OT.
- Conditions
- Loss of Smell, Olfactory Disorder
- Being tested
- Olfactory training
- Keywords
- Olfactory training, Olfaction, Smell, Hyposmia, Anosmia, Olfactory Disfunction
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory trainingOther
Also called Smell training, Smell Rehabilitation, Olfactory Rehabilitation
Olfactory training will be performed by sniffing four specific essential oils twice daily for 30 seconds each. Participants are encouraged to visualize the item they are smelling, while they perform the procedure, in a quiet room, with their eyes closed. The odors will comprise four major odor categories: flowery (phenyl ethyl alcohol/rose), aromatic (eucalyptol), fruity (citronellal/lemon), and resinous (eugenol).
| Study group | Role | What they receive |
|---|---|---|
| Olfactory training - Culinary arts students | Experimental | Students in culinary skill training program will perform olfactory training by sniffing four specific essential oils twice daily, over the entire semester (4-month period). The odors will comprise four major odor categories: flowery (phenyl ethyl alcohol/rose), aromatic (eucalyptol), fruity (citronellal/lemon), and resinous (eugenol). They will be assessed before and after the school semester. Receives: Other: Olfactory training |
| Control group - Culinary arts students | No intervention | Students in culinary skill training program will be assessed before and after the school semester, without any intervention throughout this period. |
| Olfactory training - Information Technology students | Experimental | Students in Information Technology program will perform olfactory training by sniffing four specific essential oils twice daily, over the entire semester (4-month period). The odors will comprise four major odor categories: flowery (phenyl ethyl alcohol/rose), aromatic (eucalyptol), fruity (citronellal/lemon), and resinous (eugenol). They will be assessed before and after the school semester. Receives: Other: Olfactory training |
| Control group - Information Technology students | No intervention | Students in Information Technology program will be assessed before and after the school semester, without any intervention throughout this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odor threshold discrimination identification scores
Changes from Baseline (before the school semester) on Sniffin Stick test scores considering the three olfactory dimensions (threshold, discrimination, and identification). Higher scores in this test mean better olfactory status.
Measured: Baseline, 4 months (after school semester)
Secondary outcomes (2)
Subjective odor awareness
Changes from Baseline (before the school semester) on the Odor Awareness Scale. The Odor Awareness Scale questionnaire evaluates the effects of odors on attention, emotion, memory, product purchase, and the sensitivity and importance of odors. This questionnaire broadly covers odor situations pertaining to eating, drinking, nature, and social interactions. Higher scores in this test mean better olfactory status and better odor awareness.
Measured: Baseline, 4 months (after school semester)
Olfactory specific quality of life
Changes from Baseline (before the school semester) on the Odor Awareness Scale. The Odor Awareness Scale questionnaire evaluates the effects of odors on attention, emotion, memory, product purchase, and the sensitivity and importance of odors. This questionnaire broadly covers odor situations pertaining to eating, drinking, nature, and social interactions. Higher scores in this test mean better olfactory status and better olfactory-specific quality of life.
Measured: Baseline, 4 months (after school semester)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start25 Sep 2023
- Primary completion25 Sep 2024 (estimated)
- Study completion21 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Loss of SmellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leigh Sowerby
- Sponsor type
- University, hospital or other
- Collaborators
- Fanshawe College
- Responsible party
- Sponsor-investigator, Leigh Sowerby, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066307
- Sponsor's protocol ID
- 23-06-11-1
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan CH, Faraji F, Prajapati DP, Boone CE, DeConde AS. Association of chemosensory dysfunction and COVID-19 in patients presenting with influenza-like symptoms. Int Forum Allergy Rhinol. 2020 Jul;10(7):806-813. doi: 10.1002/alr.22579. Epub 2020 Jun 1.
PubMed 32279441Pence TS, Reiter ER, DiNardo LJ, Costanzo RM. Risk factors for hazardous events in olfactory-impaired patients. JAMA Otolaryngol Head Neck Surg. 2014 Oct;140(10):951-5. doi: 10.1001/jamaoto.2014.1675.
PubMed 25170573McCrickerd K, Forde CG. Sensory influences on food intake control: moving beyond palatability. Obes Rev. 2016 Jan;17(1):18-29. doi: 10.1111/obr.12340. Epub 2015 Dec 11.
PubMed 26662879Boesveldt S, Parma V. The importance of the olfactory system in human well-being, through nutrition and social behavior. Cell Tissue Res. 2021 Jan;383(1):559-567. doi: 10.1007/s00441-020-03367-7. Epub 2021 Jan 12.
PubMed 33433688Philpott CM, Boak D. The impact of olfactory disorders in the United kingdom. Chem Senses. 2014 Oct;39(8):711-8. doi: 10.1093/chemse/bju043. Epub 2014 Sep 8.
PubMed 25201900Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.
PubMed 19235739Pekala K, Chandra RK, Turner JH. Efficacy of olfactory training in patients with olfactory loss: a systematic review and meta-analysis. Int Forum Allergy Rhinol. 2016 Mar;6(3):299-307. doi: 10.1002/alr.21669. Epub 2015 Dec 1.
PubMed 26624966Hummel T, Whitcroft KL, Andrews P, Altundag A, Cinghi C, Costanzo RM, Damm M, Frasnelli J, Gudziol H, Gupta N, Haehne A, Holbrook E, Hong SC, Hornung D, Huttenbrink KB, Kamel R, Kobayashi M, Konstantinidis I, Landis BN, Leopold DA, Macchi A, Miwa T, Moesges R, Mullol J, Mueller CA, Ottaviano G, Passali GC, Philpott C, Pinto JM, Ramakrishnan VJ, Rombaux P, Roth Y, Schlosser RA, Shu B, Soler G, Stjarne P, Stuck BA, Vodicka J, Welge-Luessen A. Position paper on olfactory dysfunction. Rhinol Suppl. 2017 Mar;54(26):1-30. doi: 10.4193/Rhino16.248.
PubMed 29528615Fornazieri MA, Garcia ECD, Lopes NMD, Miyazawa INI, Silva GDS, Monteiro RDS, Pinna FR, Voegels RL, Doty RL. Adherence and Efficacy of Olfactory Training as a Treatment for Persistent Olfactory Loss. Am J Rhinol Allergy. 2020 Mar;34(2):238-248. doi: 10.1177/1945892419887895. Epub 2019 Nov 25. No abstract available.
PubMed 31766853Altundag A, Cayonu M, Kayabasoglu G, Salihoglu M, Tekeli H, Saglam O, Hummel T. Modified olfactory training in patients with postinfectious olfactory loss. Laryngoscope. 2015 Aug;125(8):1763-6. doi: 10.1002/lary.25245. Epub 2015 Jun 2.
PubMed 26031472Greenberg MI, Curtis JA, Vearrier D. The perception of odor is not a surrogate marker for chemical exposure: a review of factors influencing human odor perception. Clin Toxicol (Phila). 2013 Feb;51(2):70-6. doi: 10.3109/15563650.2013.767908.
PubMed 23387344Majid A. Human Olfaction at the Intersection of Language, Culture, and Biology. Trends Cogn Sci. 2021 Feb;25(2):111-123. doi: 10.1016/j.tics.2020.11.005. Epub 2020 Dec 18.
PubMed 33349546Huisman JLA, Majid A. Psycholinguistic variables matter in odor naming. Mem Cognit. 2018 May;46(4):577-588. doi: 10.3758/s13421-017-0785-1.
PubMed 29435824Spence C. Perceptual learning in the chemical senses: A review. Food Res Int. 2019 Sep;123:746-761. doi: 10.1016/j.foodres.2019.06.005. Epub 2019 Jun 5.
PubMed 31285024
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Performance in Culinary Arts Students
- ClinicalTrials.gov ID
- NCT06066307
- Acronym / sponsor ID
- 23-06-11-1
- Conditions
- Loss of Smell, Olfactory Disorder
- Keywords
- Olfactory training, Olfaction, Smell, Hyposmia, Anosmia, Olfactory Disfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Leigh SowerbyUniversity, hospital or other
- Collaborators
- Fanshawe College
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 21 Nov 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic brought impaired smell and taste to the forefront of international public awareness and clinical importance. Loss of smell can impair awareness of environmental hazards, alter appetite, and have negative effects on social behavior and well-being. Despite the significant functional impact associated with impaired olfaction, few effective treatments are available. Olfactory training (OT), the mainstay of treatment, is a self-administered therapy which involves a routine of repetitive brief odor exposures over several weeks. The process has been shown to improve odor discrimination, identification and detection threshold. However, the structured design and daily time commitment may be difficult to adopt for some patients, leading to poor compliance. Moreover, OT only exposes patients to a limited number of odours, failing to replicate the complexity of odor mixtures experienced daily in our chemosensory environment. OT has mainly been studied with four conventional odours encompassing the major odor categories; phenyl ethyl alcohol/rose (flowery odor), eucalyptol (aromatic), citronellal/lemon (fruity), and eugenol (clove) (resinous); however, this neglects the importance of emphasizing odors that culturally specific or personally relevant to the patient. For some patients, these factors could hinder their ability to adopt and comply with therapy.
In contrast, cooking is a culturally ubiquitous activity that is already performed daily by most people, and naturally exposes us to personally meaningful and culturally relevant odors. However, there have been no published studies investigating the impact that odors encountered during meal preparation have on olfactory performance and development. The present study aims to compare the olfactory effects of culinary skills training to those of a conventionally designed OT program. To achieve this, olfactory testing will be conducted on students enrolled in a professional culinary skills training program at Fanshawe College, and a control group consisting of students in non-olfactory dependent programs at the same institution. To compare the effect of cooking to conventional OT, the study will be repeated for a second semester and students will be asked to perform concurrent OT.
Detailed description
This factorially designed randomized control trial is designed to compare the effects of a culinary skills training program to a typical olfactory training program on olfactory ability, awareness, and quality of life. Students enrolled in a culinary skills training program and those in a different discipline with no relevant dependence on olfactory function (information technology) will have their olfactory performance assessed before and after the completion of the program semester. The investigators will then repeat the experiment in the subsequent semester with a new group of students, asking them to perform routine OT throughout the semester.
Objective olfactory assessment will be performed with the Sniffin'Sticks olfactory test kit (Burghart, Wedel, Germany). Additionally, they will be asked to complete questionnaires that evaluate their olfactory awareness, the 32-item Odor Awareness Scale. The study aims to compare the effect of routine exposure to the chemosensory environment of cooking with conventional odor training (OT) in improving olfactory function.
Hypothesis and Objectives Objective 1: To compare the effect of culinary skill training to a control group on objective olfactory performance, subjective olfactory awareness and olfactory related quality of life.
- Hypothesis 1: Participants who complete a semester of culinary skill training will experience improvements in odor threshold discrimination identification scores compared to students studying in non-chemosensory dependent fields.
- Hypothesis 2: Participants who complete a semester of culinary skill training will experience improvements in subjective odor awareness compared to students studying in non- chemosensory dependent fields.
- Hypothesis 3: Participants who complete a semester of culinary skill training will experience improvements in olfactory specific quality of life compared to students studying in non- chemosensory dependent fields.
Objective 2: To compare the effect of culinary skill training with OT to conventional OT on objective olfactory performance, subjective olfactory awareness and olfactory related quality of life
- Hypothesis 1: Participants who complete a semester of culinary skill training with OT will experience further improvements in odor their threshold discrimination identification scores.
- Hypothesis 2: Participants who complete a semester of culinary skill training with OT will experience improvements in subjective odor awareness that are greater in magnitude to the improvements gained by participants practicing OT.
- Hypothesis 3: Participants who complete a semester of culinary skill training with OT will experience improvements in olfactory specific quality of life that are greater in magnitude to the improvements gained by participants practicing OT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Olfactory training - Culinary arts students | Experimental | Other: Olfactory trainingStudents in culinary skill training program will perform olfactory training by sniffing four specific essential oils twice daily, over the entire semester (4-month period). The odors will comprise four major odor categories: flowery (phenyl ethyl alcohol/rose), aromatic (eucalyptol), fruity (citronellal/lemon), and resinous (eugenol). They will be assessed before and after the school semester. |
| Control group - Culinary arts students | No intervention | –Students in culinary skill training program will be assessed before and after the school semester, without any intervention throughout this period. |
| Olfactory training - Information Technology students | Experimental | Other: Olfactory trainingStudents in Information Technology program will perform olfactory training by sniffing four specific essential oils twice daily, over the entire semester (4-month period). The odors will comprise four major odor categories: flowery (phenyl ethyl alcohol/rose), aromatic (eucalyptol), fruity (citronellal/lemon), and resinous (eugenol). They will be assessed before and after the school semester. |
| Control group - Information Technology students | No intervention | –Students in Information Technology program will be assessed before and after the school semester, without any intervention throughout this period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- enrolled in an introductory training program at Fanshawe collage (Culinary arts or Information Technology)
- capable of providing informed written consent
- capable of reading and writing in English
Key exclusion criteria (1 listed)
- Participants with a history of anosmia, and chronic sinus disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactory trainingAlso: Smell training, Smell Rehabilitation, Olfactory RehabilitationOlfactory training will be performed by sniffing four specific essential oils twice daily for 30 seconds each. Participants are encouraged to visualize the item they are smelling, while they perform the procedure, in a quiet room, with their eyes closed. The odors will comprise four major odor categories: flowery (phenyl ethyl alcohol/rose), aromatic (eucalyptol), fruity (citronellal/lemon), and resinous (eugenol). | Other | Olfactory training - Culinary arts students, Olfactory training - Information Technology students |
Primary outcome
Odor threshold discrimination identification scores
Time frame: Baseline, 4 months (after school semester)
Changes from Baseline (before the school semester) on Sniffin Stick test scores considering the three olfactory dimensions (threshold, discrimination, and identification). Higher scores in this test mean better olfactory status.
2 secondary outcomes
Subjective odor awareness
Time frame: Baseline, 4 months (after school semester)
Olfactory specific quality of life
Time frame: Baseline, 4 months (after school semester)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 32279441Yan CH, Faraji F, Prajapati DP, Boone CE, DeConde AS. Association of chemosensory dysfunction and COVID-19 in patients presenting with influenza-like symptoms. Int Forum Allergy Rhinol. 2020 Jul;10(7):806-813. doi: 10.1002/alr.22579. Epub 2020 Jun 1.
- Background: PubMed 25170573Pence TS, Reiter ER, DiNardo LJ, Costanzo RM. Risk factors for hazardous events in olfactory-impaired patients. JAMA Otolaryngol Head Neck Surg. 2014 Oct;140(10):951-5. doi: 10.1001/jamaoto.2014.1675.
- Background: PubMed 26662879McCrickerd K, Forde CG. Sensory influences on food intake control: moving beyond palatability. Obes Rev. 2016 Jan;17(1):18-29. doi: 10.1111/obr.12340. Epub 2015 Dec 11.
- Background: PubMed 33433688Boesveldt S, Parma V. The importance of the olfactory system in human well-being, through nutrition and social behavior. Cell Tissue Res. 2021 Jan;383(1):559-567. doi: 10.1007/s00441-020-03367-7. Epub 2021 Jan 12.
- Background: PubMed 25201900Philpott CM, Boak D. The impact of olfactory disorders in the United kingdom. Chem Senses. 2014 Oct;39(8):711-8. doi: 10.1093/chemse/bju043. Epub 2014 Sep 8.
- Background: PubMed 19235739Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.
- Background: PubMed 26624966Pekala K, Chandra RK, Turner JH. Efficacy of olfactory training in patients with olfactory loss: a systematic review and meta-analysis. Int Forum Allergy Rhinol. 2016 Mar;6(3):299-307. doi: 10.1002/alr.21669. Epub 2015 Dec 1.
- Background: PubMed 29528615Hummel T, Whitcroft KL, Andrews P, Altundag A, Cinghi C, Costanzo RM, Damm M, Frasnelli J, Gudziol H, Gupta N, Haehne A, Holbrook E, Hong SC, Hornung D, Huttenbrink KB, Kamel R, Kobayashi M, Konstantinidis I, Landis BN, Leopold DA, Macchi A, Miwa T, Moesges R, Mullol J, Mueller CA, Ottaviano G, Passali GC, Philpott C, Pinto JM, Ramakrishnan VJ, Rombaux P, Roth Y, Schlosser RA, Shu B, Soler G, Stjarne P, Stuck BA, Vodicka J, Welge-Luessen A. Position paper on olfactory dysfunction. Rhinol Suppl. 2017 Mar;54(26):1-30. doi: 10.4193/Rhino16.248.
- Background: PubMed 31766853Fornazieri MA, Garcia ECD, Lopes NMD, Miyazawa INI, Silva GDS, Monteiro RDS, Pinna FR, Voegels RL, Doty RL. Adherence and Efficacy of Olfactory Training as a Treatment for Persistent Olfactory Loss. Am J Rhinol Allergy. 2020 Mar;34(2):238-248. doi: 10.1177/1945892419887895. Epub 2019 Nov 25. No abstract available.
- Background: PubMed 26031472Altundag A, Cayonu M, Kayabasoglu G, Salihoglu M, Tekeli H, Saglam O, Hummel T. Modified olfactory training in patients with postinfectious olfactory loss. Laryngoscope. 2015 Aug;125(8):1763-6. doi: 10.1002/lary.25245. Epub 2015 Jun 2.
- Background: PubMed 23387344Greenberg MI, Curtis JA, Vearrier D. The perception of odor is not a surrogate marker for chemical exposure: a review of factors influencing human odor perception. Clin Toxicol (Phila). 2013 Feb;51(2):70-6. doi: 10.3109/15563650.2013.767908.
- Background: PubMed 33349546Majid A. Human Olfaction at the Intersection of Language, Culture, and Biology. Trends Cogn Sci. 2021 Feb;25(2):111-123. doi: 10.1016/j.tics.2020.11.005. Epub 2020 Dec 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olfactory training in people with Loss of Smell and Olfactory Disorder, run by Leigh Sowerby at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taciano Rocha, Ph.D, ACRP-CP (5196466100 ext. 61125, taciano.rocha@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odor threshold discrimination identification scores (time frame: Baseline, 4 months (after school semester)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066307, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.