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NCT05364125 | Recruiting | Olfaction Disorders


Olfactory Training on Smell Dysfunction Patients in HK
Sponsor:

Pamela Youde Nethersole Eastern Hospital

Information provided by (Responsible Party):

Fergus Wong Kai Chuen

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.

Condition or disease

Olfaction Disorders

Smell Disorders

Anosmia

Hyposmia

Olfactory Impairment

Smell Loss

Smell Dysfunction

Intervention/treatment

Olfactory Training

Control

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 80 participants
Masking : Single
Masking Description : Randomly assigned by computer into treatment group and control group
Primary Purpose : Treatment
Official Title : Effect of Olfactory Training on Olfactory Dysfunction Patients in Hong Kong Population
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025
Arm Intervention/treatment

Experimental: 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.

Other: Olfactory Training

Placebo Comparator: 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.

Other: Control

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Olfactory Training on Smell Dysfunction Patients in HK

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Olfactory Training on Smell Dysfunction Patients in HK

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Locations


Recruiting

Hong Kong,

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong,

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