Olfactory Training on Smell Dysfunction Patients in HK

Not Applicable

Recruiting

• Conditions: Smell Loss; Olfactory Impairment; Olfaction Disorders; Smell Disorders; Hyposmia; Anosmia; Smell Dysfunction
• Interventions: Other: Control; Other: Olfactory Training

• Registration Number: NCT05364125
• Lead Sponsor: Pamela Youde Nethersole Eastern Hospital

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.

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 Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Study Start: 2022-07-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Control	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.
Treatment arm	Olfactory Training	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.

Primary Outcome Measures

Name	Time	Method
Olfactory identification score changes after olfactory training after 3 months	3 months after starting smell training	Parameter: Olfactory identification using Smell Identification Test (UPSIT)
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)
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)
Olfactory threshold changes after olfactory training after 3 months	3 months after starting smell training	Parameter: Olfactory threshold using Butanol Threshold Test (BTT)

Trial Locations

Locations (1)

Pamela Youde Nethersole Eastern Hospital; 🇭🇰 Hong Kong, Hong Kong