Olfactory Training on Smell Dysfunction Patients in HK

Anosmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364125
• Other study ID #: OlfactoryTrainingHKRCT
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Pamela Youde Nethersole Eastern Hospital
• Contact: Kai Chuen Fergus Wong, FRCSEd(ORL)
• Phone: 64600771
• Email: wkc568[@]ha.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anosmia
• Hyposmia
• Olfaction Disorders
• Smell Disorders
• Smell Dysfunction

Intervention

Other:
• Olfactory Training
Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana)
• Control
Normal Saline will be used

Locations

Country	Name	City	State
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Pamela Youde Nethersole Eastern Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olfactory threshold changes after olfactory training after 3 months	Parameter: Olfactory threshold using Butanol Threshold Test (BTT)	3 months after starting smell training
Primary	Olfactory identification score changes after olfactory training after 3 months	Parameter: Olfactory identification using Smell Identification Test (UPSIT)	3 months after starting smell training
Primary	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
Primary	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