The Vietnamese Smell Identification Test in the Diagnosis of Parkinson's Disease

NCT05837637 | Unknown

• 1 other identifier: 688/HĐĐĐ-ĐHYD
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

Brief 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, 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

Conditions

Hyposmia; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• The VSIT score of both groups

  The VSIT score of both groups will be calculated after testing

  From May 2023 to May 2025

Secondary Outcomes (1)

• The BSIT score of both groups

  From May 2023 to May 2025

Study Arms (2)

Parkinson's disease patients

Parkinson's disease patients attend the Parkinson and Movement disorder clinic at Ho Chi Minh University Medical Center

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

Diagnostic Test: The Vietnamese Smell Identification test (VSIT), the Brief Smell Identification test (BSIT)

Interventions

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

Parkinson's disease patients; healthy control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Aged 18 years and older
• MMSE score \> 24
• Clinical diagnosis of Parkinson's disease (for patient group)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

Ho Chi Minh University Medical Center

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Anosmia; Parkinson Disease

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Thi Huyen Thuong Dang

  Ho Chi Minh University Medical Center

  PRINCIPAL INVESTIGATOR

• Ngoc Tai Tran, Doctor

  Ho Chi Minh University Medical Center

  STUDY DIRECTOR

Central Study Contacts

Thi Huyen Thuong Dang, Master

CONTACT

+84907587738; thuong.dth@umc.edu.vn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: May 5, 2023
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-04

Locations

VN (1)