Clinical trial NCT05364125: Olfactory Training on Smell Dysfunction Patients in HK
Official title: Effect of Olfactory Training on Olfactory Dysfunction Patients in Hong Kong Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Olfaction Disorders
Smell Disorders
Anosmia
Hyposmia
Olfactory Impairment
Smell Loss
Smell Dysfunction
Lead sponsor: Pamela Youde Nethersole Eastern Hospital
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Olfactory threshold changes after olfactory training after 3 months
timeFrame: 3 months after starting smell training
measure: Olfactory identification score changes after olfactory training after 3 months
timeFrame: 3 months after starting smell training
measure: Quality of life changes after olfactory training after 3 months
timeFrame: 3 months after starting smell training
measure: Taste and smell changes after olfactory training after 3 months
timeFrame: 3 months after starting smell training
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
Study officials:
affiliation: Pamela Youde Nethersole Eastern Hospital
name: Kai Chuen Fergus Wong, FRCSEd(ORL)
role: PRINCIPAL_INVESTIGATOR
References: