Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06066307
Other study ID # 23-06-11-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 25, 2023
Est. completion date November 21, 2024

Study information

Verified date October 2023
Source Lawson Health Research Institute
Contact Taciano Rocha, Ph.D, ACRP-CP
Phone 5196466100
Email taciano.rocha@sjhc.london.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 21, 2024
Est. primary completion date September 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Participants with a history of anosmia, and chronic sinus disease.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Olfactory training
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).

Locations

Country Name City State
Canada Fanshawe College London Ontario

Sponsors (2)

Lead Sponsor Collaborator
Leigh Sowerby Fanshawe College

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Altundag 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. — View Citation

Boesveldt 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. — View Citation

Fornazieri 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. — View Citation

Greenberg 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. — View Citation

Huisman JLA, Majid A. Psycholinguistic variables matter in odor naming. Mem Cognit. 2018 May;46(4):577-588. doi: 10.3758/s13421-017-0785-1. — View Citation

Hummel 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. — View Citation

Hummel 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. — View Citation

Majid 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. — View Citation

McCrickerd 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. — View Citation

Pekala 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. — View Citation

Pence 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. — View Citation

Philpott 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. — View Citation

Spence 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. — View Citation

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 4 months (after school semester)
Secondary 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. Baseline, 4 months (after school semester)
Secondary 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. Baseline, 4 months (after school semester)
See also
  Status Clinical Trial Phase
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02985515 - Steroid Nasal Irrigation for Flavor Evaluation and Detection Study N/A
Completed NCT05445921 - Stellate Ganglion Block for COVID-19-Induced Olfactory Dysfunction Phase 1/Phase 2
Recruiting NCT05855369 - Smell Training and Trigeminal Nerve Stimulation for COVID-related Smell Loss Phase 2/Phase 3
Recruiting NCT03574701 - Intranasal Retinoic Acid Treatment for Patients With OlfactoryLOSS: A RANDOMIZED CONTROLLED TRIAL N/A
Enrolling by invitation NCT04764981 - Olfactory Training for Olfactory Dysfunction After Coronavirus Disease - 19 (COVID-19) N/A
Completed NCT03990766 - Smell Changes & Efficacy of Nasal Theophylline Phase 2
Withdrawn NCT05542095 - Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia Phase 1
Recruiting NCT04791436 - Oral and Olfactory Complications of Recovered COVID-19 Patients
Enrolling by invitation NCT05038475 - Clinical and Immunological Responses After SARS-CoV-2 Infection Causing COVID-19
Completed NCT01332825 - cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose N/A
Completed NCT04789499 - Smell in Covid-19 and Efficacy of Nasal Theophylline Phase 2
Active, not recruiting NCT04761458 - Correlation of Preoperative Global Olfactory Function With Frailty, Perioperative Neurocognitive Disorders and Mortality N/A
Completed NCT04406584 - Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction N/A
Completed NCT03611673 - At-Home Olfactory Training N/A
Completed NCT04700891 - Correlation of Preoperative Olfactory Identification Function With Frailty and Postoperative Complications and Mortality N/A
Recruiting NCT04466982 - Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection
Recruiting NCT04869436 - Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis Phase 4
Recruiting NCT05448898 - The Efficacy of Traditional Chinese Medicine in Olfactory Dysfunction N/A
Completed NCT04235153 - CAncer, NUtrition and Taste - Validation of the CANUT-QVA Questionnaire on Eating Habits in Cancer Patients