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NCT Number: NCT05364125

Olfactory Training on Smell Dysfunction Patients in HK

* 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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamela Youde Nethersole Eastern Hospital

Hong Kong

Location status: Recruiting

Location contact

Kai-Chuen, Fergus Wong

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olfactory Training

Other

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

Control

Other

Normal Saline will be used

Primary outcomes

  1. Olfactory threshold changes after olfactory training after 3 months

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 3 months after starting smell training

    Parameter:

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ka Chung Kwan, FRCSEd(ORL)

CONTACT

64600056

Kai Chuen Fergus Wong, FRCSEd(ORL)

CONTACT

[email protected]

64600771

Sponsors and collaborators

Lead sponsor

Pamela Youde Nethersole Eastern Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 6, 2022
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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