Olfactory Training on Smell Dysfunction Patients in HK

NCT ID: NCT05364125

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-06-30

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Randomly assigned by computer into treatment group and control group

Study Groups

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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.

Group Type EXPERIMENTAL

Olfactory Training

Intervention Type OTHER

Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana)

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

Normal Saline will be used

Interventions

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Olfactory Training

Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana)

Intervention Type OTHER

Control

Normal Saline will be used

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamela Youde Nethersole Eastern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fergus Wong Kai Chuen

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Chuen Fergus Wong, FRCSEd(ORL)

Role: PRINCIPAL_INVESTIGATOR

Pamela Youde Nethersole Eastern Hospital

Locations

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Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Kai Chuen Fergus Wong, FRCSEd(ORL)

Role: CONTACT

Ka Chung Kwan, FRCSEd(ORL)

Role: CONTACT

64600056

Facility Contacts

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Kai-Chuen, Fergus Wong

Role: primary

Other Identifiers

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OlfactoryTrainingHKRCT

Identifier Type: -

Identifier Source: org_study_id

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