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临床试验/NCT06066307
NCT06066307招募中4 期

Olfactory Performance in Culinary Arts Students

Leigh Sowerby1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年9月25日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Odor threshold discrimination identification scores

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Research staff involved in the smell tests and questionnaires administration will not be aware of the subjects allocation (whether OT or control)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: Olfactory training (Other)

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.

干预措施: Olfactory training (Other)

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.

结局指标

主要结局

Odor threshold discrimination identification scores

时间窗: 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.

次要结局

  • Subjective odor awareness(Baseline, 4 months (after school semester))
  • Olfactory specific quality of life(Baseline, 4 months (after school semester))

研究者

发起方
Leigh Sowerby
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leigh Sowerby

MD, MHM, FRCSC

Lawson Health Research Institute

研究点 (1)

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