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

NCT05837637 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 218

Last updated 2023-11-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • University Medical Center Ho Chi Minh City (UMC)

    lead OTHER

Principal Investigators

  • Thi Huyen Thuong Dang · Ho Chi Minh University Medical Center

  • Ngoc Tai Tran, Doctor · Ho Chi Minh University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2024-12-01
Completion
2025-09-01

Countries

  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05837637 on ClinicalTrials.gov