Olfactory Training on Smell Dysfunction Patients in HK

• Sponsor: Pamela Youde Nethersole Eastern Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05364125
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

• 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.

Condition or Disease	Intervention/Treatment	Phase
Olfaction Disorders; Smell Disorders; Anosmia; Hyposmia; Olfactory Impairment; Smell Loss; Smell Dysfunction	Other: Olfactory Training; Other: Control	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Randomly assigned by computer into treatment group and control group
• Primary Purpose: Treatment
• Official Title: Effect of Olfactory Training on Olfactory Dysfunction Patients in Hong Kong Population
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment arm 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; Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana)
Placebo Comparator: Control arm 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; Normal Saline will be used

Outcome Measures

Primary Outcome Measures

1. Olfactory threshold changes after olfactory training after 3 months [3 months after starting smell training]

   Parameter: Olfactory threshold using Butanol Threshold Test (BTT)

2. Olfactory identification score changes after olfactory training after 3 months [3 months after starting smell training]

   Parameter: Olfactory identification using Smell Identification Test (UPSIT)

3. Quality of life changes after olfactory training after 3 months [3 months after starting smell training]

   Parameter: Subjective quality of life score using Sino-Nasal Outcome Test (SNOT-22)

4. Taste and smell changes after olfactory training after 3 months [3 months after starting smell training]

   Parameter: Subjective smell and taste assessment using Visual Analogue Scale (VAS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamela Youde Nethersole Eastern Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• Pamela Youde Nethersole Eastern Hospital

Investigators

• Principal Investigator: Kai Chuen Fergus Wong, FRCSEd(ORL), Pamela Youde Nethersole Eastern Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fergus Wong Kai Chuen, Associate Consultant, Pamela Youde Nethersole Eastern Hospital
• ClinicalTrials.gov Identifier: NCT05364125
• Other Study ID Numbers: OlfactoryTrainingHKRCT
• First Posted: May 6, 2022
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anosmia; Olfaction Disorders; Disease

Study Results

No Results Posted as of May 10, 2022