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Clinical Trials/NCT05364125
NCT05364125
Recruiting
Not Applicable

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

Pamela Youde Nethersole Eastern Hospital1 site in 1 country80 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Olfaction Disorders
Sponsor
Pamela Youde Nethersole Eastern Hospital
Enrollment
80
Locations
1
Primary Endpoint
Olfactory identification score changes after olfactory training after 3 months
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
June 30, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fergus Wong Kai Chuen

Associate Consultant

Pamela Youde Nethersole Eastern Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

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)

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)

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)

Study Sites (1)

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