NCT06066307

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2024

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 27, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

Olfactory trainingOlfactionSmellHyposmiaAnosmiaOlfactory Disfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Subjective odor awareness

    Baseline, 4 months (after school semester)

  • Olfactory specific quality of life

    Baseline, 4 months (after school semester)

Study Arms (4)

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.

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.

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.

Interventions

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).

Also known as: Smell training, Smell Rehabilitation, Olfactory Rehabilitation
Olfactory training - Culinary arts studentsOlfactory training - Information Technology students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participants with a history of anosmia, and chronic sinus disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fanshawe College

London, Ontario, N5Y 5R6, Canada

RECRUITING

Related Publications (14)

  • 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.

    PMID: 32279441BACKGROUND
  • 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.

    PMID: 25170573BACKGROUND
  • 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.

    PMID: 26662879BACKGROUND
  • 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.

    PMID: 33433688BACKGROUND
  • 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.

    PMID: 25201900BACKGROUND
  • 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.

    PMID: 19235739BACKGROUND
  • 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.

    PMID: 26624966BACKGROUND
  • 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.

    PMID: 29528615BACKGROUND
  • 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.

    PMID: 31766853BACKGROUND
  • 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.

    PMID: 26031472BACKGROUND
  • 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.

    PMID: 23387344BACKGROUND
  • 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.

    PMID: 33349546BACKGROUND
  • 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.

    PMID: 29435824BACKGROUND
  • 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.

    PMID: 31285024BACKGROUND

MeSH Terms

Conditions

Anosmia

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Taciano Rocha, Ph.D, ACRP-CP

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research staff involved in the smell tests and questionnaires administration will not be aware of the subjects allocation (whether OT or control)
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, MHM, FRCSC

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 4, 2023

Study Start

September 25, 2023

Primary Completion

September 25, 2024

Study Completion

November 21, 2024

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations