Olfactory Training on Smell Dysfunction Patients in HK
Primary Purpose
Olfaction Disorders, Smell Disorders, Anosmia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Olfactory Training
Control
Sponsored by
About this trial
This is an interventional treatment trial for Olfaction Disorders
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.
Sites / Locations
- Pamela Youde Nethersole Eastern HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment arm
Control arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Olfactory threshold changes after olfactory training after 3 months
Parameter:
Olfactory threshold using Butanol Threshold Test (BTT)
Olfactory identification score changes after olfactory training after 3 months
Parameter:
Olfactory identification using Smell Identification Test (UPSIT)
Quality of life changes after olfactory training after 3 months
Parameter:
Subjective quality of life score using Sino-Nasal Outcome Test (SNOT-22)
Taste and smell changes after olfactory training after 3 months
Parameter:
Subjective smell and taste assessment using Visual Analogue Scale (VAS)
Secondary Outcome Measures
Full Information
NCT ID
NCT05364125
First Posted
April 14, 2022
Last Updated
September 28, 2022
Sponsor
Pamela Youde Nethersole Eastern Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05364125
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamela Youde Nethersole Eastern Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olfaction Disorders, Smell Disorders, Anosmia, Hyposmia, Olfactory Impairment, Smell Loss, Smell Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Randomly assigned by computer into treatment group and control group
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Olfactory Training
Intervention Description
Four aromatic substances will be used (Citrus limon, Eucalyptus radiata, Pelargonium graveolens, Juniperus virginiana)
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Normal Saline will be used
Primary Outcome Measure Information:
Title
Olfactory threshold changes after olfactory training after 3 months
Description
Parameter:
Olfactory threshold using Butanol Threshold Test (BTT)
Time Frame
3 months after starting smell training
Title
Olfactory identification score changes after olfactory training after 3 months
Description
Parameter:
Olfactory identification using Smell Identification Test (UPSIT)
Time Frame
3 months after starting smell training
Title
Quality of life changes after olfactory training after 3 months
Description
Parameter:
Subjective quality of life score using Sino-Nasal Outcome Test (SNOT-22)
Time Frame
3 months after starting smell training
Title
Taste and smell changes after olfactory training after 3 months
Description
Parameter:
Subjective smell and taste assessment using Visual Analogue Scale (VAS)
Time Frame
3 months after starting smell training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Chuen Fergus Wong, FRCSEd(ORL)
Phone
64600771
Email
wkc568@ha.org.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Chung Kwan, FRCSEd(ORL)
Phone
64600056
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Chuen Fergus Wong, FRCSEd(ORL)
Organizational Affiliation
Pamela Youde Nethersole Eastern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Chuen, Fergus Wong
12. IPD Sharing Statement
Plan to Share IPD
No
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Olfactory Training on Smell Dysfunction Patients in HK
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