Olfactory Training on Smell Dysfunction Patients in HK

Study Overview
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Brief Summary
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Causes of olfactory dysfunction can be classified into conductive and sensorineural causes. Conductive causes are mainly due to structural nasal problem, which can be treated by nasal surgery Sensorineural causes included post-infection, post-head injury, post Head and Neck irradiation and other central nervous system diseases. Olfactory Training is well established treatment for sensorineural olfactory dysfunction in foreign countries. Olfactory Training by neurological chemosensory stimulation using aromatic substances delivered via electronic portable aromatic rehabilitation (EPAR) diffuser was proved to be effective treatment in COVID-19 related olfactory dysfunction in recent Hong Kong study. However, there is a lack of local study on the effect of Olfactory Training in other non-COVID-19 sensorineural causes of olfactory dysfunction in Hong Kong population.

Detailed Description
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Design Prospective double-blinded randomized control trial. Study Period 1/7/2022 - 30/6/2024 for case recruitment. Suitable patient will be recruited. Informed consent will be signed. Objective smell assessment will be done using the University of Pennsylvania Smell Identification Test (UPSIT) and Butanol Threshold Test (BTT). Subjective quality of life score will be obtained by Sino-Nasal Outcome Test (SNOT-22). Subjective smell and taste assessment will be assessed by Visual Analogue Scale (VAS). Patient will be randomized into treatment group and control group using computer generated list by an independent nursing staff. Doctors and the patients will be blinded during the study.

Official Title
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Effect of Olfactory Training on Olfactory Dysfunction Patients in Hong Kong Population

Conditions
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Olfaction Disorders, Smell Disorders, Anosmia, Hyposmia, Olfactory Impairment, Smell Loss, Smell Dysfunction

Intervention / Treatment
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* Other: Olfactory Training
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Olfactory dysfunction > 6 months and < 5 years Exclusion Criteria: History of significant head injury (fracture, ICH) History of brain surgery History of nasal surgery Active nasal disease Active neurological disease Poor premorbid status/ non-communicable patients Mentally incompetent patients <18 years' old Pregnancy Hypersensitivity to the aromatic substance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Olfactory training by neurological chemosensory stimulation using aromatic substances delivered via diffusers. Four aromatic substances will be used. Each substance will be given for 20 seconds sequentially, providing a total of 80 seconds of olfactory stimulation three times per day for 3 months. | Other: Olfactory Training<br>* Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana)<br>|
| Placebo Comparator: Control arm<br>Same diffuser will be given to control group. All of the four essential oils will be replaced by normal saline using the same packing. Same treatment regime of 20 seconds for each diffuser three times per day for 3 months will be instructed to control group patients. | Other: Control<br>* Normal Saline will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Olfactory threshold changes after olfactory training after 3 months | Parameter: Olfactory threshold using Butanol Threshold Test (BTT) | 3 months after starting smell training | 
| Olfactory identification score changes after olfactory training after 3 months | Parameter: Olfactory identification using Smell Identification Test (UPSIT) | 3 months after starting smell training | 
| Quality of life changes after olfactory training after 3 months | Parameter: Subjective quality of life score using Sino-Nasal Outcome Test (SNOT-22) | 3 months after starting smell training | 
| Taste and smell changes after olfactory training after 3 months | Parameter: Subjective smell and taste assessment using Visual Analogue Scale (VAS) | 3 months after starting smell training |