HyposmiaNCT05837637
The Vietnamese Smell Identification Test in the Diagnosis of Parkinson's Disease
An observational study of Hyposmia and Parkinson Disease, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
The goal of this observational study is to assess the value of the Vietnamese smell identification test (VSIT) in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, Brisk smell identification test (BSIT) The main questions it aims to answer are: The sensitivity, specificity… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyposmia, Parkinson Disease
- What is being tested?
- The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)
- How many people
- 218 participants
- Where
- 1 siteVietnam
- Study dates
- 5 May 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population: Parkinson's disease patients and healthy control Target Population: 1. Parkinson's disease patients attend the Parkinson and Movement disorder clinic at Ho Chi Minh University Medical Center Control Population: 1. The participants included hospital staffs and relatives of patients that matched age and sex
Who may be able to join
- Aged 18 years and older
- MMSE score > 24
- Clinical diagnosis of Parkinson's disease (for patient group)
Who cannot join
- History of trauma to the head, history of nasal bone fracture, and history of nasal cosmetic surgery
- Brain neoplasms
- History of stroke, epilepsy
- Secondary Parkinson's and Parkinson's Plus
- Other neurodegenerative diseases, such as Alzheimer's
- Mental disorders, such as schizophrenia, depression
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- Upper respiratory tract infections in the 2 weeks
- Pregnancy
- Exposure to medications relating to olfactory reduction, for instance, some particular antibiotics, antiepileptics, antithyroid or benzodiazepines
- Having reported COVID-19 compatible smell symptomatology
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Ho Chi Minh University Medical Center
Ho Chi Minh City, 700000
Thi Huyen Thuong Dang, +840907587738, thuong.dth@umc.edu.vn
About this study
Official title: Validation of the Utility of the Vietnamese Smell Identification Test in Vietnamese Patients With Parkinson's Disease
The goal of this observational study is to assess the value of the Vietnamese smell identification test (VSIT) in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, Brisk smell identification test (BSIT)
The main questions it aims to answer are:
Read more
- The sensitivity, specificity, positive predictive value, and negative predictive value of the VSIT in the diagnosis of Parkinson's disease?
- The sensitivity, specificity, positive predictive value, and negative predictive value of the BSIT in the diagnosis of Parkinson's disease?
- Factors that associated with olfactory identification ability in PD patients?
Process:
- Participants will be assessed cognitive station using MMSE
- Information on socio-demographic including age, gender, education, occupation, place of residence of both groups, and disease-related characteristics will be collected.
- Participants with Parkinson disease will be then assessed with the following instruments: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Hoehn \& Yarh scale, and Beck Depression Inventory
- The case and control groups will be assessed by the Vietnamese Smell Identification Test and Brisk Smell Identification Test
Read the detailed description
Rational Parkinson's disease is one of the most commonly neurodegenerative disorders neurological outbreaks with an incidence in Vietnam of 80-90/100,000 people. It comprises of motor and non-motor symptoms (NMS). Motor symptoms include tremor, bradykinesia, rigidity, gait difficulties, postural instability and falls. Non-motor symptoms are diverse including a wide range of symptoms involving almost systems of the body. A number of nonmotor symptoms may precede motor symptoms by several years, including olfactory dysfunction, constipation, REM sleep behavior disorder, and depression. Since1975, after Ansari and Johnson reported impaired olfactory function in Parkinson's patients, many studies have been conducted with the goal of demonstrating a diminished sense of smell in Parkinson's patients. Recent studies have noted that 70-90% of Parkinson's patients have hyposmia. Current evidence suggests that Parkinson's patients may experience disturbances in various aspects of olfactory function including odor detection, odor discrimination, and odor perception. However, some studies indicated that odor recognition function was more often affected than odor discrimination function. Nowadays, hyposmia is one of the supportive criteria in the diagnosis of Parkinson's disease based on the Parkinson's disease diagnostic criteria of the Movement Disorders Association. Besides, hyposmia when combined with other signs on DAT-Scan and on transcranial Doppler ultrasound help increase the accuracy in diagnosing Parkinson's disease.
There are many different tests available on the market to assess olfactory function for Parkinson's patients, of which the most commonly used tests are UPSIT (University of Pennsylvania Smell Identification Test), B-SIT (Brief Smell Identification test). Identification Test) and Sniffin's Sticks. UPSIT is an odor identification test, developed in 1984 with 40 different odorants. UPSIT has been shown to be highly reliable and valuable in the assessment of odor disorders 19. However, evaluating UPSIT took a long time, so a simpler version of UPSIT with 12 different flavors suitable for many cultures was created called B-SIT. These 12 scents were selected from surveys conducted in several countries in North America, South America, Europe and Asia. In Asia, surveys were conducted in Japan and China. Many studies have shown that B-SIT has good sensitivity and specificity in the diagnosis of Parkinson's disease. However, the popular assessment methods including UPSIT, B-SIT and Sniffin's Sticks were all developed in other parts of the world, so there are many odors in these tests that are not familiar to Vietnamese people. The 12-item Vietnamese smell identification test (VSIT) has been developed to evaluate olfactory function for the Vietnamese population. The VSIT demonstrated good validity and reliability. To date, there have been no studies evaluating the effectiveness of odor identification tests in diagnosing Parkinson's disease in Vietnam. Therefore, investigators conducted this study with the aim to assess the value of the VSIT in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, B-SIT.
Primary research objective:
- To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the VSIT in the diagnosis of Parkinson's disease?
Secondary research objective:
- To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the BSIT in the diagnosis of Parkinson's disease?
- To find factors that associated with olfactory identification ability in PD patients?
Approach to participants:
- Patients and controls attending the Parkinson and Movement disorder clinic at UMC will be approached by one of the researchers about the study when the patients come for their regular visit
Research Process:
- Participants will be assessed cognitive station using MMSE
- Information on socio-demographic including age, sex, education, occupation, place of residence of both groups, and disease-related characteristics will be collected.
- Participants with PD will be then assessed with the following instruments: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Hoehn \& Yarh scale, and Beck Depression Inventory
- The case and control groups will be assessed by the Vietnamese Smell Identification Test and Brisk Smell Identification Test
- Conditions
- Hyposmia, Parkinson Disease
- Being tested
- The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)
- Medical subject headings
- Anosmia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)Diagnostic test
- The VSIT: Odorants used in the VSIT are odorous liquids commercially available in Vietnam. Cotton buds are dipped in diluted odor solution and are used as test materials. The cotton swab is then packaged in a sterile and non-volatile sachet. Participants tore the cotton swab-containing sachet in the direction of the arrow to reveal the bud of the cotton swab and place it approximately 2 cm from the nostrils for 2-3 seconds. The score based on the number of correct answers ranges from 0 to 12.
- The BSIT: BSIT will be purchased from Sensoics, Inc. and used according to the manufacturer's instructions. Odorants are microencapsulated on the paper and odors are released when the subject uses a pencil to scratch the microcapsule coating. Odorants are placed 2 cm from the both nostrils and participants selected the smell from the answer card containing four options for each odorant. The score based on the number of correct answers ranges from 0 to 12
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients attend the Parkinson and Movement disorder clinic at Ho Chi Minh University Medical Center Receives: Diagnostic Test: The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT) | |
| healthy control | The participants including hospital staffs and relatives of patients that matched age and gender Receives: Diagnostic Test: The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The VSIT score of both groups
The VSIT score of both groups will be calculated after testing
Measured: From May 2023 to May 2025
Secondary outcomes (1)
The BSIT score of both groups
The BSIT score of both groups will be calculated after testing
Measured: From May 2023 to May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start5 May 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyposmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thi Huyen Thuong Dang, Principal investigator, Ho Chi Minh University Medical CenterNgoc Tai Tran, Doctor, Study director, Ho Chi Minh University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837637
- Sponsor's protocol ID
- 688/HĐĐĐ-ĐHYD
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share study protocol, SAP, ICF, CSR
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Utility of the Vietnamese Smell Identification Test in Vietnamese Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05837637
- Acronym / sponsor ID
- 688/HĐĐĐ-ĐHYD
- Conditions
- Hyposmia, Parkinson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess the value of the Vietnamese smell identification test (VSIT) in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, Brisk smell identification test (BSIT)
The main questions it aims to answer are:
- The sensitivity, specificity, positive predictive value, and negative predictive value of the VSIT in the diagnosis of Parkinson's disease?
- The sensitivity, specificity, positive predictive value, and negative predictive value of the BSIT in the diagnosis of Parkinson's disease?
- Factors that associated with olfactory identification ability in PD patients?
Process:
- Participants will be assessed cognitive station using MMSE
- Information on socio-demographic including age, gender, education, occupation, place of residence of both groups, and disease-related characteristics will be collected.
- Participants with Parkinson disease will be then assessed with the following instruments: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Hoehn \& Yarh scale, and Beck Depression Inventory
- The case and control groups will be assessed by the Vietnamese Smell Identification Test and Brisk Smell Identification Test
Detailed description
Rational Parkinson's disease is one of the most commonly neurodegenerative disorders neurological outbreaks with an incidence in Vietnam of 80-90/100,000 people. It comprises of motor and non-motor symptoms (NMS). Motor symptoms include tremor, bradykinesia, rigidity, gait difficulties, postural instability and falls. Non-motor symptoms are diverse including a wide range of symptoms involving almost systems of the body. A number of nonmotor symptoms may precede motor symptoms by several years, including olfactory dysfunction, constipation, REM sleep behavior disorder, and depression. Since1975, after Ansari and Johnson reported impaired olfactory function in Parkinson's patients, many studies have been conducted with the goal of demonstrating a diminished sense of smell in Parkinson's patients. Recent studies have noted that 70-90% of Parkinson's patients have hyposmia. Current evidence suggests that Parkinson's patients may experience disturbances in various aspects of olfactory function including odor detection, odor discrimination, and odor perception. However, some studies indicated that odor recognition function was more often affected than odor discrimination function. Nowadays, hyposmia is one of the supportive criteria in the diagnosis of Parkinson's disease based on the Parkinson's disease diagnostic criteria of the Movement Disorders Association. Besides, hyposmia when combined with other signs on DAT-Scan and on transcranial Doppler ultrasound help increase the accuracy in diagnosing Parkinson's disease.
There are many different tests available on the market to assess olfactory function for Parkinson's patients, of which the most commonly used tests are UPSIT (University of Pennsylvania Smell Identification Test), B-SIT (Brief Smell Identification test). Identification Test) and Sniffin's Sticks. UPSIT is an odor identification test, developed in 1984 with 40 different odorants. UPSIT has been shown to be highly reliable and valuable in the assessment of odor disorders 19. However, evaluating UPSIT took a long time, so a simpler version of UPSIT with 12 different flavors suitable for many cultures was created called B-SIT. These 12 scents were selected from surveys conducted in several countries in North America, South America, Europe and Asia. In Asia, surveys were conducted in Japan and China. Many studies have shown that B-SIT has good sensitivity and specificity in the diagnosis of Parkinson's disease. However, the popular assessment methods including UPSIT, B-SIT and Sniffin's Sticks were all developed in other parts of the world, so there are many odors in these tests that are not familiar to Vietnamese people. The 12-item Vietnamese smell identification test (VSIT) has been developed to evaluate olfactory function for the Vietnamese population. The VSIT demonstrated good validity and reliability. To date, there have been no studies evaluating the effectiveness of odor identification tests in diagnosing Parkinson's disease in Vietnam. Therefore, investigators conducted this study with the aim to assess the value of the VSIT in the diagnosis of Parkinson's disease, and compare it with the commonly used test in the world, B-SIT.
Primary research objective:
- To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the VSIT in the diagnosis of Parkinson's disease?
Secondary research objective:
- To determine the sensitivity, specificity, positive predictive value, and negative predictive value of the BSIT in the diagnosis of Parkinson's disease?
- To find factors that associated with olfactory identification ability in PD patients?
Approach to participants:
- Patients and controls attending the Parkinson and Movement disorder clinic at UMC will be approached by one of the researchers about the study when the patients come for their regular visit
Research Process:
- Participants will be assessed cognitive station using MMSE
- Information on socio-demographic including age, sex, education, occupation, place of residence of both groups, and disease-related characteristics will be collected.
- Participants with PD will be then assessed with the following instruments: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Hoehn \& Yarh scale, and Beck Depression Inventory
- The case and control groups will be assessed by the Vietnamese Smell Identification Test and Brisk Smell Identification Test
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Diagnostic Test: The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)Parkinson's disease patients attend the Parkinson and Movement disorder clinic at Ho Chi Minh University Medical Center |
| healthy control | – | Diagnostic Test: The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)The participants including hospital staffs and relatives of patients that matched age and gender |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population: Parkinson's disease patients and healthy control Target Population: 1. Parkinson's disease patients attend the Parkinson and Movement disorder clinic at Ho Chi Minh University Medical Center Control Population: 1. The participants included hospital staffs and relatives of patients that matched age and sex
Key inclusion criteria (3 listed)
- Aged 18 years and older
- MMSE score > 24
- Clinical diagnosis of Parkinson's disease (for patient group)
Key exclusion criteria (10 listed)
- History of trauma to the head, history of nasal bone fracture, and history of nasal cosmetic surgery
- Brain neoplasms
- History of stroke, epilepsy
- Secondary Parkinson's and Parkinson's Plus
- Other neurodegenerative diseases, such as Alzheimer's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)* The VSIT: Odorants used in the VSIT are odorous liquids commercially available in Vietnam. Cotton buds are dipped in diluted odor solution and are used as test materials. The cotton swab is then packaged in a sterile and non-volatile sachet. Participants tore the cotton swab-containing sachet in the direction of the arrow to reveal the bud of the cotton swab and place it approximately 2 cm from the nostrils for 2-3 seconds. The score based on the number of correct answers ranges from 0 to 12. * The BSIT: BSIT will be purchased from Sensoics, Inc. and used according to the manufacturer's instructions. Odorants are microencapsulated on the paper and odors are released when the subject uses a pencil to scratch the microcapsule coating. Odorants are placed 2 cm from the both nostrils and participants selected the smell from the answer card containing four options for each odorant. The score based on the number of correct answers ranges from 0 to 12 | Diagnostic test | Parkinson's disease patients, healthy control |
Primary outcome
The VSIT score of both groups
Time frame: From May 2023 to May 2025
The VSIT score of both groups will be calculated after testing
1 secondary outcome
The BSIT score of both groups
Time frame: From May 2023 to May 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Undecided. We will share study protocol, SAP, ICF, CSR
Related trials for Hyposmia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thi Huyen Thuong Dang principal investigator
Ho Chi Minh University Medical Center
Ngoc Tai Tran, Doctor study director
Ho Chi Minh University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyposmia and Parkinson Disease, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thi Huyen Thuong Dang, Master (+84907587738, thuong.dth@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The VSIT score of both groups (time frame: From May 2023 to May 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.